Obsessive-Compulsive Disorder
Conditions
Brief summary
The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.
Interventions
DEVICETranscranial 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)
Sponsors
Butler Hospital
University of Minnesota
Bradley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-18 years * Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale * Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions * Right-handed * If taking psychotropic medications, these have been stable for \> 6 weeks and are expected to remain stable for the approximately 3-week study protocol * If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol)
Exclusion criteria
* • Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration) * Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips) * Active suicidality or psychosis * Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability * Substance abuse or dependence * Taking a stimulant medication (and unwilling to forgo on study visit days) * Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics) * Patient is a ward of the state * Family history of epilepsy * History of syncope
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Response Time on Stop Trials of the Stop Signal Task | Change from pre (within 1 hour before) to post (within 1 hour after) intervention | Computerized task, where shorter response time (in milliseconds) indicates better performance |
| Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | Change from pre (within 1 hour before) to post (within 1 hour after) intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Symptom Question | post (within 1 hour after) intervention | Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All enrolled participants were randomly assigned to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 3 |
| 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) | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.7 years STANDARD_DEVIATION 1.2 | 16.3 years STANDARD_DEVIATION 1 | 15.1 years STANDARD_DEVIATION 1.7 |
| Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) | 24.0 units on a scale STANDARD_DEVIATION 1.7 | 24.3 units on a scale STANDARD_DEVIATION 5.3 | 24.1 units on a scale STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex/Gender, Customized Female | 2 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Male | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Nonbinary | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 1 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
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).
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS | Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | 0.5 microvolts (µV) | Standard Deviation 2.9 |
| Sham (Fake) TMS | Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | 1.5 microvolts (µV) | Standard Deviation 2.2 |
Primary
Change in Response Time on Stop Trials of the Stop Signal Task
Computerized task, where shorter response time (in milliseconds) indicates better performance
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Population: Does not include data from one participant who withdrew prior to completing the measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS | Change in Response Time on Stop Trials of the Stop Signal Task | -26.2 milliseconds | Standard Deviation 102.1 |
| Sham (Fake) TMS | Change in Response Time on Stop Trials of the Stop Signal Task | -31.7 milliseconds | Standard Deviation 123.1 |
Secondary
Self-report Symptom Question
Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions
Time frame: post (within 1 hour after) intervention
Population: Does not include one participant who withdrew before completing measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS | Self-report Symptom Question | 2.7 units on a scale | Standard Deviation 1.4 |
| Sham (Fake) TMS | Self-report Symptom Question | 2.5 units on a scale | Standard Deviation 2.1 |