Trial Outcomes & Findings for Neuromodulation Therapy for Task-Specific Dystonia (NCT NCT06422104)
NCT ID: NCT06422104
Last Updated: 2026-04-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Pre-TMS and post-TMS session (each session is approximately 45 minutes)
Results posted on
2026-04-13
Participant Flow
The study was a cross-over design with multiple visits and measures to compare differences in data within participants across the three TMS conditions. Healthy volunteers were not enrolled in the trial represented in this results submission.
Participant milestones
| Measure |
PMC, PSC, Sham
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by Sham rTMS: Sham rTMS to PMC
|
PMC, Sham, PSC
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex
|
PSC, PMC, Sham
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by Sham rTMS: Sham rTMS to PMC
|
Sham, PMC, PSC
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, Sham rTMS: Sham rTMS to PMC Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex
|
PSC, Sham, PMC
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex
|
Sham, PSC, PMC
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, Sham rTMS: Sham rTMS to PMC Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex
|
|---|---|---|---|---|---|---|
|
First TMS Visit (1 Day)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
First TMS Visit (1 Day)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
First TMS Visit (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Washout (1 Week)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second TMS Visit (1 Day)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Second TMS Visit (1 Day)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Second TMS Visit (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third TMS Visit (1 Day)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Third TMS Visit (1 Day)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Third TMS Visit (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromodulation Therapy for Task-Specific Dystonia
Baseline characteristics by cohort
| Measure |
PMC, PSC, Sham
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by Sham rTMS: Sham rTMS to PMC
|
PMC, Sham, PSC
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex
|
PSC, PMC, Sham
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by Sham rTMS: Sham rTMS to PMC
|
Sham, PMC, PSC
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, Sham rTMS: Sham rTMS to PMC Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex
|
PSC, Sham, PMC
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex
|
Sham, PSC, PMC
n=2 Participants
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits.
First, Sham rTMS: Sham rTMS to PMC Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
2 Participants
n=539 Participants
|
9 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
2 Participants
n=539 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
2 Participants
n=539 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=193 Participants
|
2 participants
n=193 Participants
|
2 participants
n=386 Participants
|
2 participants
n=112 Participants
|
2 participants
n=103 Participants
|
2 participants
n=539 Participants
|
12 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-TMS and post-TMS session (each session is approximately 45 minutes)Outcome measures
| Measure |
rTMS to Premotor Cortex (PMC)
n=12 Participants
10 Hz rTMS to premotor cortex
|
rTMS to Primary Somatosensory Cortex (PSC)
n=12 Participants
10 Hz rTMS to primary somatosensory cortex
|
Sham rTMS
n=12 Participants
Sham rTMS to premotor cortex
|
|---|---|---|---|
|
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions
|
12 Participants
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During TMS session (each session is approximately 45 minutes)Population: Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis.
Outcome measures
| Measure |
rTMS to Premotor Cortex (PMC)
n=12 Participants
10 Hz rTMS to premotor cortex
|
rTMS to Primary Somatosensory Cortex (PSC)
n=12 Participants
10 Hz rTMS to primary somatosensory cortex
|
Sham rTMS
n=11 Participants
Sham rTMS to premotor cortex
|
|---|---|---|---|
|
Safety, as Measured by TMS Acute Side Effects
|
0 acute side affects
|
0 acute side affects
|
0 acute side affects
|
SECONDARY outcome
Timeframe: Pre-TMS and post-TMS session (each session is approximately 45 minutes)Population: Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis.
Change in peak accelerations behaviors pre- and post-TMS is calculated by taking the change in peak accelerations from behavior performed before and after each TMS visit. Higher measures of peak accelerations represent greater writing dysfluency and worsening dystonia.
Outcome measures
| Measure |
rTMS to Premotor Cortex (PMC)
n=12 Participants
10 Hz rTMS to premotor cortex
|
rTMS to Primary Somatosensory Cortex (PSC)
n=12 Participants
10 Hz rTMS to primary somatosensory cortex
|
Sham rTMS
n=11 Participants
Sham rTMS to premotor cortex
|
|---|---|---|---|
|
Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).
|
99.00 percentage of pre-TMS session
Standard Error 0.90
|
96.43 percentage of pre-TMS session
Standard Error 1.39
|
100.06 percentage of pre-TMS session
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Post-TMS session (each session is approximately 45 minutes)Population: Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis.
Brain connectivity was assessed using functional magnetic resonance imaging of the brain. The z-score is mathematical calculation of the synchronization between brain regions. Specifically, functional connectivity z-scores quantify the strength of synchronization between brain regions by transforming Pearson correlation coefficients (r-values) into normally distributed values (z-scores). This Fisher-z transformation stabilizes variance, enabling valid group-level statistical comparisons (e.g., t-tests) of functional connectivity. Positive Z-scores (Z scores\> 0) represent stronger synchronization between brain regions and strengthening of connectivity between brain regions; negative Z-scores (Z-scores \<0) indicate anti-synchronization between brain regions and weakening of connectivity between brain regions.
Outcome measures
| Measure |
rTMS to Premotor Cortex (PMC)
n=12 Participants
10 Hz rTMS to premotor cortex
|
rTMS to Primary Somatosensory Cortex (PSC)
n=12 Participants
10 Hz rTMS to primary somatosensory cortex
|
Sham rTMS
n=11 Participants
Sham rTMS to premotor cortex
|
|---|---|---|---|
|
Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII
|
0.28 z-score
Standard Error 0.03
|
0.27 z-score
Standard Error 0.04
|
0.44 z-score
Standard Error 0.03
|
Adverse Events
rTMS to Premotor Cortex (PMC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
rTMS to Primary Somatosensory Cortex (PSC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Noreen Bukhari-Parlakturk, MD PhD
Duke University Medical Center
Phone: (919) 684-8704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place