Trial Outcomes & Findings for Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease (NCT NCT07309198)
NCT ID: NCT07309198
Last Updated: 2026-06-24
Results Overview
Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
TIs Group
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
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|---|---|---|
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Overall Study
STARTED
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19
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18
|
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Overall Study
COMPLETED
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19
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18
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
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Total
n=37 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
67.95 years
STANDARD_DEVIATION 7.86 • n=20 Participants
|
72.56 years
STANDARD_DEVIATION 4.93 • n=20 Participants
|
70.19 years
STANDARD_DEVIATION 6.91 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Parkinson's Disease duration
|
7.37 years
STANDARD_DEVIATION 3.22 • n=20 Participants
|
6.89 years
STANDARD_DEVIATION 2.59 • n=20 Participants
|
7.14 years
STANDARD_DEVIATION 2.90 • n=40 Participants
|
|
levodopa equivalent daily dose
|
696.10 mg
STANDARD_DEVIATION 280.80 • n=20 Participants
|
533.68 mg
STANDARD_DEVIATION 171.31 • n=20 Participants
|
617.08 mg
STANDARD_DEVIATION 245.07 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
8 weeks after intervention (T5)
|
-7.403 scores
Standard Error 1.563
|
-0.892 scores
Standard Error 1.584
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
immediately after 1 weeks of intervention (T1)
|
-6.724 scores
Standard Error 1.539
|
-2.603 scores
Standard Error 1.538
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
immediately after 2 weeks of intervention (T2)
|
-8.303 scores
Standard Error 1.539
|
-1.214 scores
Standard Error 1.538
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
2 weeks after intervention (T3)
|
-8.330 scores
Standard Error 1.597
|
-1.477 scores
Standard Error 1.579
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
4 weeks after intervention (T4)
|
-7.913 scores
Standard Error 1.581
|
-3.645 scores
Standard Error 1.583
|
PRIMARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Population: The intention-to-treat population included all randomized participants who received at least 1 stimulation session and had at least 1 post-baseline assessment for this outcome. Analyses were conducted in the ITT population using generalized estimating equations with available data and no imputation of missing outcome values. Therefore, the number analyzed in each row reflects the number of participants with observed data at that specific time point.
A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
immediately after 1 weeks of intervention (T1)
|
15 Participants
|
6 Participants
|
|
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
immediately after 2 weeks of intervention (T2)
|
15 Participants
|
4 Participants
|
|
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
2 weeks after intervention (T3)
|
13 Participants
|
5 Participants
|
|
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
4 weeks after intervention (T4)
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12 Participants
|
5 Participants
|
|
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
8 weeks after intervention (T5)
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11 Participants
|
5 Participants
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SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
immediately after 1 weeks of intervention (T1)
|
-2.241 scores
Standard Error 1.120
|
-0.849 scores
Standard Error 1.144
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
immediately after 2 weeks of intervention (T2)
|
-2.294 scores
Standard Error 1.120
|
-1.515 scores
Standard Error 1.144
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
2 weeks after intervention (T3)
|
-2.368 scores
Standard Error 1.151
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-2.196 scores
Standard Error 1.186
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
4 weeks after intervention (T4)
|
-2.907 scores
Standard Error 1.137
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-1.400 scores
Standard Error 1.196
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
8 weeks after intervention (T5)
|
-2.647 scores
Standard Error 1.148
|
0.490 scores
Standard Error 1.198
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SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
immediately after 1 weeks of intervention (T1)
|
-3.873 scores
Standard Error 1.215
|
-1.146 scores
Standard Error 1.239
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
immediately after 2 weeks of intervention (T2)
|
-4.767 scores
Standard Error 1.215
|
-2.702 scores
Standard Error 1.239
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
2 weeks after intervention (T3)
|
-3.699 scores
Standard Error 1.242
|
-1.694 scores
Standard Error 1.275
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
4 weeks after intervention (T4)
|
-4.439 scores
Standard Error 1.228
|
-2.308 scores
Standard Error 1.276
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
8 weeks after intervention (T5)
|
-3.544 scores
Standard Error 1.237
|
-1.558 scores
Standard Error 1.276
|
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in daytime sleepiness assessed using the Epworth Sleepiness Scale . The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2. The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions. Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials. Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Changes in balance performance will be assessed using a force platform during standardized standing balance tasks. Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability. Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and immediately after the interventionChanges in brain structure and/or function will be assessed using magnetic resonance imaging (MRI). MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
8 weeks after intervention (T5)
|
-4.553 scores
Standard Error 0.697
|
-0.205 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
immediately after 1 weeks of intervention (T1)
|
-3.362 scores
Standard Error 0.662
|
-1.913 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
immediately after 2 weeks of intervention (T2)
|
-5.047 scores
Standard Error 0.662
|
-0.913 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
2 weeks after intervention (T3)
|
-3.833 scores
Standard Error 0.741
|
-0.330 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
4 weeks after intervention (T4)
|
-5.148 scores
Standard Error 0.718
|
-1.455 scores
Standard Error 0.719
|
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
immediately after 1 weeks of intervention (T1)
|
-0.152 scores
Standard Error 0.662
|
0.163 scores
Standard Error 0.697
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
immediately after 2 weeks of intervention (T2)
|
0.059 scores
Standard Error 0.662
|
0.532 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
2 weeks after intervention (T3)
|
-1.354 scores
Standard Error 0.718
|
0.734 scores
Standard Error 0.698
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
4 weeks after intervention (T4)
|
-0.402 scores
Standard Error 0.718
|
0.795 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
8 weeks after intervention (T5)
|
-0.788 scores
Standard Error 0.697
|
0.607 scores
Standard Error 0.719
|
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
immediately after 1 weeks of intervention (T1)
|
-0.994 scores
Standard Error 0.662
|
-0.913 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
immediately after 2 weeks of intervention (T2)
|
-0.836 scores
Standard Error 0.662
|
-0.968 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
2 weeks after intervention (T3)
|
-1.416 scores
Standard Error 0.718
|
-1.518 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
4 weeks after intervention (T4)
|
-0.714 scores
Standard Error 0.718
|
-1.580 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
8 weeks after intervention (T5)
|
-0.435 scores
Standard Error 0.697
|
-0.768 scores
Standard Error 0.719
|
SECONDARY outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
8 weeks after intervention (T5)
|
-1.494 scores
Standard Error 0.697
|
-0.330 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
immediately after 1 weeks of intervention (T1)
|
-2.152 scores
Standard Error 0.662
|
0.198 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
immediately after 2 weeks of intervention (T2)
|
-2.520 scores
Standard Error 0.662
|
0.254 scores
Standard Error 0.678
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
2 weeks after intervention (T3)
|
-2.354 scores
Standard Error 0.718
|
-0.327 scores
Standard Error 0.719
|
|
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
4 weeks after intervention (T4)
|
-1.027 scores
Standard Error 0.718
|
-1.205 scores
Standard Error 0.719
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weekly averages during weeks 1 and 2 of the interventionThe motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Week 1 average
|
0.192 percentage of waking time
Standard Error 0.038
|
0.042 percentage of waking time
Standard Error 0.038
|
|
Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Week 2 average
|
0.200 percentage of waking time
Standard Error 0.038
|
0.049 percentage of waking time
Standard Error 0.038
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weekly averages during weeks 1 and 2 of the interventionThe motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)
Week 1 average
|
-0.022 percentage of waking time
Standard Error 0.010
|
0.009 percentage of waking time
Standard Error 0.010
|
|
Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)
Week 2 average
|
-0.027 percentage of waking time
Standard Error 0.010
|
0.014 percentage of waking time
Standard Error 0.010
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
immediately after 1 weeks of intervention (T1)
|
-6.067 scores
Standard Error 1.642
|
-0.923 scores
Standard Error 1.674
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
immediately after 2 weeks of intervention (T2)
|
-5.877 scores
Standard Error 1.642
|
-3.538 scores
Standard Error 1.674
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
2 weeks after intervention (T3)
|
-5.570 scores
Standard Error 1.670
|
-4.435 scores
Standard Error 1.714
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
4 weeks after intervention (T4)
|
-5.098 scores
Standard Error 1.657
|
-2.812 scores
Standard Error 1.726
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
8 weeks after intervention (T5)
|
-6.188 scores
Standard Error 1.668
|
-0.840 scores
Standard Error 1.730
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
immediately after 1 weeks of intervention (T1)
|
-10.213 scores
Standard Error 3.231
|
-0.312 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
immediately after 2 weeks of intervention (T2)
|
-10.345 scores
Standard Error 3.231
|
-4.340 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
2 weeks after intervention (T3)
|
-9.257 scores
Standard Error 3.320
|
-3.673 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
4 weeks after intervention (T4)
|
-12.711 scores
Standard Error 3.278
|
-3.226 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
8 weeks after intervention (T5)
|
-13.454 scores
Standard Error 3.310
|
-1.040 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
immediately after 1 weeks of intervention (T1)
|
-9.906 scores
Standard Error 3.231
|
-2.488 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
immediately after 2 weeks of intervention (T2)
|
-11.880 scores
Standard Error 3.231
|
-5.729 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
2 weeks after intervention (T3)
|
-12.164 scores
Standard Error 3.320
|
-4.833 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
4 weeks after intervention (T4)
|
-9.966 scores
Standard Error 3.278
|
-5.238 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
8 weeks after intervention (T5)
|
-10.072 scores
Standard Error 3.310
|
1.683 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
immediately after 1 weeks of intervention (T1)
|
-0.696 scores
Standard Error 3.231
|
-2.257 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
immediately after 2 weeks of intervention (T2)
|
-3.766 scores
Standard Error 3.231
|
-5.960 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
2 weeks after intervention (T3)
|
-1.926 scores
Standard Error 3.320
|
-3.717 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
4 weeks after intervention (T4)
|
-2.169 scores
Standard Error 3.278
|
-2.604 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
8 weeks after intervention (T5)
|
-1.164 scores
Standard Error 3.310
|
-0.070 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
2 weeks after intervention (T3)
|
2.135 scores
Standard Error 3.320
|
-10.775 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
immediately after 1 weeks of intervention (T1)
|
-1.792 scores
Standard Error 3.231
|
-1.215 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
immediately after 2 weeks of intervention (T2)
|
2.484 scores
Standard Error 3.231
|
-0.868 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
4 weeks after intervention (T4)
|
5.888 scores
Standard Error 3.278
|
-3.442 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
8 weeks after intervention (T5)
|
2.143 scores
Standard Error 3.310
|
-4.676 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
immediately after 1 weeks of intervention (T1)
|
-0.477 scores
Standard Error 3.231
|
1.910 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
immediately after 2 weeks of intervention (T2)
|
-0.915 scores
Standard Error 3.231
|
2.836 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
2 weeks after intervention (T3)
|
-2.399 scores
Standard Error 3.320
|
-0.291 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
4 weeks after intervention (T4)
|
-1.863 scores
Standard Error 3.278
|
1.229 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
8 weeks after intervention (T5)
|
-2.535 scores
Standard Error 3.310
|
6.341 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
immediately after 1 weeks of intervention (T1)
|
-11.661 scores
Standard Error 3.231
|
-3.993 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
immediately after 2 weeks of intervention (T2)
|
-8.371 scores
Standard Error 3.231
|
-9.201 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
2 weeks after intervention (T3)
|
-10.755 scores
Standard Error 3.320
|
-9.705 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
4 weeks after intervention (T4)
|
-8.780 scores
Standard Error 3.278
|
-6.003 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
8 weeks after intervention (T5)
|
-9.294 scores
Standard Error 3.310
|
-8.699 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
immediately after 1 weeks of intervention (T1)
|
-7.055 scores
Standard Error 3.231
|
0.984 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
immediately after 2 weeks of intervention (T2)
|
-7.933 scores
Standard Error 3.231
|
-2.719 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
2 weeks after intervention (T3)
|
-5.655 scores
Standard Error 3.320
|
0.027 scores
Standard Error 3.429
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
4 weeks after intervention (T4)
|
-6.001 scores
Standard Error 3.278
|
3.193 scores
Standard Error 3.456
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
8 weeks after intervention (T5)
|
-6.703 scores
Standard Error 3.310
|
4.861 scores
Standard Error 3.429
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.
Outcome measures
| Measure |
TIs Group
n=19 Participants
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 Participants
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
immediately after 1 weeks of intervention (T1)
|
-7.055 scores
Standard Error 3.231
|
0.521 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
immediately after 2 weeks of intervention (T2)
|
-6.617 scores
Standard Error 3.231
|
-1.794 scores
Standard Error 3.313
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
2 weeks after intervention (T3)
|
-5.274 scores
Standard Error 3.320
|
-1.974 scores
Standard Error 3.433
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
4 weeks after intervention (T4)
|
-5.957 scores
Standard Error 3.279
|
-5.726 scores
Standard Error 3.476
|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
8 weeks after intervention (T5)
|
-8.585 scores
Standard Error 3.335
|
-4.226 scores
Standard Error 3.492
|
Adverse Events
TIs Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Sham Stimulation Group
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIs Group
n=19 participants at risk
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 participants at risk
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
5.6%
1/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
Other adverse events
| Measure |
TIs Group
n=19 participants at risk
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
|
Sham Stimulation Group
n=18 participants at risk
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period.
|
|---|---|---|
|
General disorders
Scalp pain
|
0.00%
0/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
11.1%
2/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
|
General disorders
Itching
|
15.8%
3/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
22.2%
4/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
|
General disorders
Tingling
|
68.4%
13/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
88.9%
16/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
|
General disorders
Burning
|
5.3%
1/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
0.00%
0/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
0.00%
0/18 • From enrollment through the final follow-up visit 8 weeks after completion of the 2-week intervention period, for an overall adverse-event monitoring period of approximately 10 weeks.
Adverse events were collected from enrollment through the end of follow-up. Stimulation-related side effects were assessed at each stimulation session using a standardized checklist, and other adverse events occurring during the study period were recorded through spontaneous participant reports and follow-up assessments. For this parallel-group study, the number at risk was the number of participants assigned to each group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place