Trial Outcomes & Findings for TMS for Improving Response Inhibition in Adolescents With OCD (NCT NCT05104697)
NCT ID: NCT05104697
Last Updated: 2025-01-28
Results Overview
Computerized task, where shorter response time (in milliseconds) indicates better performance
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Results posted on
2025-01-28
Participant Flow
Participants were recruited from a pediatric OCD specialty clinic between March 2022 and March 2023. Note that recruitment began in March 2022 before the first participant was formally enrolled on the study start date of April 1, 2022.
All enrolled participants were randomly assigned to a study arm.
Participant milestones
| Measure |
TMS at Visit 1, Sham at Visit 2
At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
Sham at Visit 1, TMS at Visit 2
At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TMS at Visit 1, Sham at Visit 2
At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
Sham at Visit 1, TMS at Visit 2
At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
TMS for Improving Response Inhibition in Adolescents With OCD
Baseline characteristics by cohort
| Measure |
TMS at Visit 1, Sham at Visit 2
n=3 Participants
At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
Sham at Visit 1, TMS at Visit 2
n=4 Participants
At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location.
Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
16.3 years
STANDARD_DEVIATION 1.0 • n=107 Participants
|
15.1 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Nonbinary
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)
|
24.0 units on a scale
STANDARD_DEVIATION 1.7 • n=99 Participants
|
24.3 units on a scale
STANDARD_DEVIATION 5.3 • n=107 Participants
|
24.1 units on a scale
STANDARD_DEVIATION 3.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change from pre (within 1 hour before) to post (within 1 hour after) interventionPopulation: Does not include data from one participant who withdrew prior to completing the measure
Computerized task, where shorter response time (in milliseconds) indicates better performance
Outcome measures
| Measure |
Active TMS
n=6 Participants
Visits at which participants received active TMS using continuous theta burst over the preSMA. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
Sham (Fake) TMS
n=6 Participants
Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
|---|---|---|
|
Change in Response Time on Stop Trials of the Stop Signal Task
|
-26.2 milliseconds
Standard Deviation 102.1
|
-31.7 milliseconds
Standard Deviation 123.1
|
PRIMARY outcome
Timeframe: Change from pre (within 1 hour before) to post (within 1 hour after) interventionPopulation: Does not include data from two participants (one withdrew before completing the measure, one could not be analyzed due to error with EEG data capture)
Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).
Outcome measures
| Measure |
Active TMS
n=5 Participants
Visits at which participants received active TMS using continuous theta burst over the preSMA. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
Sham (Fake) TMS
n=5 Participants
Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
|---|---|---|
|
Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
|
0.5 microvolts (µV)
Standard Deviation 2.9
|
1.5 microvolts (µV)
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: post (within 1 hour after) interventionPopulation: Does not include one participant who withdrew before completing measure
Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions
Outcome measures
| Measure |
Active TMS
n=6 Participants
Visits at which participants received active TMS using continuous theta burst over the preSMA. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
Sham (Fake) TMS
n=6 Participants
Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
|---|---|---|
|
Self-report Symptom Question
|
2.7 units on a scale
Standard Deviation 1.4
|
2.5 units on a scale
Standard Deviation 2.1
|
Adverse Events
Active TMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham (Fake) TMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TMS
n=6 participants at risk
Visits at which participants received active TMS using continuous theta burst over the preSMA. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
Sham (Fake) TMS
n=6 participants at risk
Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Data were collected at one of two study visits that occurred over the course of two weeks
|
16.7%
1/6 • Number of events 1 • Data were collected at one of two study visits that occurred over the course of two weeks
|
|
Nervous system disorders
Scalp discomfort
|
16.7%
1/6 • Number of events 1 • Data were collected at one of two study visits that occurred over the course of two weeks
|
0.00%
0/6 • Data were collected at one of two study visits that occurred over the course of two weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place