Trial Outcomes & Findings for Effects of Transcranial Pulse Stimulation in Parkinson's Disease (NCT NCT06676995)
NCT ID: NCT06676995
Last Updated: 2026-08-10
Results Overview
Unified Parkinson's Disease Rating Scale (UPDRS) evaluates the motor function, non-motor symptoms (mentation, behavior, and mood), activities of daily living, and complications of therapy. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total UPDRS score is obtained by summing Parts I-IV, with a total score ranging from 0 to 199. Lower scores indicate less severe Parkinson's disease and represent a better outcome; higher scores indicate greater disease severity and represent a worse outcome. The outcome measure represents the change from Baseline to 4 weeks, immediately post-intervention (Visit 12).
COMPLETED
NA
14 participants
Baseline and 4 weeks, immediately post-intervention (Visit 12).
2026-08-10
Participant Flow
Participant milestones
| Measure |
Active TPS
The treatment protocol consisted of 12 Transcranial Pulse Stimulation (TPS) sessions administered over 4 weeks (3 sessions per week). Each session lasted approximately 50 min and involved administering 10,000 individual pulses. 8000 pulses were delivered to the brain at an energy flux density of 0.25 millijoule/millimeter (mJ/mm)2 with a repetition rate of 4 Hz and a penetration depth up to 8 cm, sufficient to modulate cortical and subcortical structures, and 2000 pulses at an energy flux density of 0.10 mJ/mm2 and 4 Hz were provided on the foot soles.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Transcranial Pulse Stimulation in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Active TPS
n=14 Participants
The treatment protocol consisted of 12 TPS sessions administered over 4 weeks (3 sessions per week). Each session lasted approximately 50 min and involved administering 10,000 individual pulses. 8000 pulses were delivered to the brain at an energy flux density of 0.25 Millijoule/millimeter2 with a repetition rate of 4 hertz and a penetration depth up to 8 cm, sufficient to modulate cortical and subcortical structures, and 2000 pulses at an energy flux density of 0.10 Millijoule/millimeter2 and 4 hertz were provided on the foot soles.
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|---|---|
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Age, Continuous
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69.36 years
STANDARD_DEVIATION 8.53 • n=54 Participants
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Sex: Female, Male
Female
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4 Participants
n=54 Participants
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Sex: Female, Male
Male
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10 Participants
n=54 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=54 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=54 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=54 Participants
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Region of Enrollment
United States
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14 participants
n=54 Participants
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Unified Parkinson's Disease Rating Scale (UPDRS)
|
47.79 units on a scale
STANDARD_DEVIATION 16.56 • n=54 Participants
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PRIMARY outcome
Timeframe: Baseline and 4 weeks, immediately post-intervention (Visit 12).Unified Parkinson's Disease Rating Scale (UPDRS) evaluates the motor function, non-motor symptoms (mentation, behavior, and mood), activities of daily living, and complications of therapy. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total UPDRS score is obtained by summing Parts I-IV, with a total score ranging from 0 to 199. Lower scores indicate less severe Parkinson's disease and represent a better outcome; higher scores indicate greater disease severity and represent a worse outcome. The outcome measure represents the change from Baseline to 4 weeks, immediately post-intervention (Visit 12).
Outcome measures
| Measure |
Active TPS
n=14 Participants
The treatment protocol consisted of 12 TPS sessions administered over 4 weeks (3 sessions per week). Each session lasted approximately 50 min and involved administering 10,000 individual pulses. 8000 pulses were delivered to the brain at an energy flux density of 0.25 mJ/mm2 with a repetition rate of 4 Hz and a penetration depth up to 8 cm, sufficient to modulate cortical and subcortical structures, and 2000 pulses at an energy flux density of 0.10 mJ/mm2 and 4 Hz were provided on the foot soles.
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|---|---|
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Unified Parkinson's Disease Rating Scale (UPDRS)
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-9.43 units on a scale
Standard Deviation 5.36
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Adverse Events
Active TPS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TPS
n=14 participants at risk
The treatment protocol consisted of 12 TPS sessions administered over 4 weeks (3 sessions per week). Each session lasted approximately 50 min and involved administering 10,000 individual pulses. 8000 pulses were delivered to the brain at an energy flux density of 0.25 mJ/mm2 with a repetition rate of 4 Hz and a penetration depth up to 8 cm, sufficient to modulate cortical and subcortical structures, and 2000 pulses at an energy flux density of 0.10 mJ/mm2 and 4 Hz were provided on the foot soles.
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|---|---|
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Skin and subcutaneous tissue disorders
Mild pain/pressure
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14.3%
2/14 • Number of events 2 • 4 weeks
Adverse events were collected using an adverse events questionnaire.
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Additional Information
Dr. Felipe Fregni
Spaulding Rehabilitation Hospital, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place