Trial Outcomes & Findings for Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics (NCT NCT04578912)
NCT ID: NCT04578912
Last Updated: 2025-03-07
Results Overview
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
baseline to post-treatment; approximately 10 days
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Active Comparator: 1 Hz rTMS
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
|
Active Comparator: cTBS
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
|
Sham Comparator: Sham
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
17
|
|
Overall Study
COMPLETED
|
17
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Baseline characteristics by cohort
| Measure |
Active Comparator: 1 Hz rTMS
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
|
Active Comparator: cTBS
n=16 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
|
Sham Comparator: Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to post-treatment; approximately 10 daysFor each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Outcome measures
| Measure |
CBIT + rTMS
n=15 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Repetitive Transcranial Magnetic Stimulation (rTMS): During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
|
CBIT + cTBS
n=13 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Continuous Theta Burst Stimulation (cTBS): During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
|
CBIT + Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
|
|---|---|---|---|
|
Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
|
0.0312 eta squared
Standard Deviation 0.05
|
0.261 eta squared
Standard Deviation 0.05
|
0.158 eta squared
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: baseline to post-treatment; approximately 10 daysFor each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Outcome measures
| Measure |
CBIT + rTMS
n=15 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Repetitive Transcranial Magnetic Stimulation (rTMS): During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
|
CBIT + cTBS
n=13 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Continuous Theta Burst Stimulation (cTBS): During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
|
CBIT + Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
|
|---|---|---|---|
|
Change in SMA Activation
|
0.45 eta squared
Standard Deviation 1.25
|
0.01 eta squared
Standard Deviation 1.25
|
0.27 eta squared
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: approximately 3-4 monthsThe number of adverse events judged to be treatment related will be totaled and reported for each group.
Outcome measures
| Measure |
CBIT + rTMS
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Repetitive Transcranial Magnetic Stimulation (rTMS): During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
|
CBIT + cTBS
n=16 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Continuous Theta Burst Stimulation (cTBS): During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
|
CBIT + Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
|
|---|---|---|---|
|
Safety: Measured as Rate of Adverse Events Related to Study Treatment
|
46 events
|
22 events
|
18 events
|
SECONDARY outcome
Timeframe: baseline to 3 months post-treatmentThe Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment.
Outcome measures
| Measure |
CBIT + rTMS
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Repetitive Transcranial Magnetic Stimulation (rTMS): During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
|
CBIT + cTBS
n=16 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Continuous Theta Burst Stimulation (cTBS): During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
|
CBIT + Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
|
|---|---|---|---|
|
Change in Tic Suppression Task
|
0.58 tics per minute
Standard Deviation 9.47
|
-3.83 tics per minute
Standard Deviation 23.92
|
-8.24 tics per minute
Standard Deviation 15.71
|
SECONDARY outcome
Timeframe: approximately 3-4 monthsFor each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.
Outcome measures
| Measure |
CBIT + rTMS
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Repetitive Transcranial Magnetic Stimulation (rTMS): During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
|
CBIT + cTBS
n=16 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
Continuous Theta Burst Stimulation (cTBS): During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
|
CBIT + Sham
n=17 Participants
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Comprehensive Behavioral Intervention for Tics (CBIT): CBIT is a manualized treatment program focused on tic management skills
|
|---|---|---|---|
|
Feasibility: Measured as Participant Treatment Completion
|
17 participants
|
15 participants
|
16 participants
|
Adverse Events
Active Comparator: 1 Hz rTMS
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Active Comparator: cTBS
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Sham Comparator: Sham
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Comparator: 1 Hz rTMS
n=17 participants at risk
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
|
Active Comparator: cTBS
n=15 participants at risk
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
|
Sham Comparator: Sham
n=16 participants at risk
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with sham stimulation.
|
|---|---|---|---|
|
General disorders
Headache
|
41.2%
7/17 • Number of events 21 • 4 months
|
40.0%
6/15 • Number of events 10 • 4 months
|
43.8%
7/16 • Number of events 9 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitch
|
41.2%
7/17 • Number of events 8 • 4 months
|
0.00%
0/15 • 4 months
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
General disorders
sleep disturbance
|
23.5%
4/17 • Number of events 5 • 4 months
|
20.0%
3/15 • Number of events 3 • 4 months
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
General disorders
Other
|
11.8%
2/17 • Number of events 2 • 4 months
|
6.7%
1/15 • Number of events 1 • 4 months
|
12.5%
2/16 • Number of events 4 • 4 months
|
|
General disorders
Mood change
|
11.8%
2/17 • Number of events 4 • 4 months
|
6.7%
1/15 • Number of events 2 • 4 months
|
0.00%
0/16 • 4 months
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 2 • 4 months
|
6.7%
1/15 • Number of events 2 • 4 months
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
General disorders
Nausea
|
5.9%
1/17 • Number of events 1 • 4 months
|
6.7%
1/15 • Number of events 2 • 4 months
|
0.00%
0/16 • 4 months
|
|
Skin and subcutaneous tissue disorders
Scalp discomfort
|
11.8%
2/17 • Number of events 2 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/16 • 4 months
|
|
General disorders
Concentration difficulties
|
5.9%
1/17 • Number of events 1 • 4 months
|
6.7%
1/15 • Number of events 1 • 4 months
|
0.00%
0/16 • 4 months
|
|
General disorders
Hearing difficulties
|
0.00%
0/17 • 4 months
|
6.7%
1/15 • Number of events 1 • 4 months
|
0.00%
0/16 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place