TMS for Improving Response Inhibition in Adolescents With OCD
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Device: Transcranial Magnetic Stimulation
- Registration Number
- NCT05104697
- Lead Sponsor
- Bradley Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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)
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• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sham at visit 1, TMS at visit 2 Transcranial Magnetic Stimulation 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. TMS at visit 1, Sham at visit 2 Transcranial Magnetic Stimulation 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Emma Pendleton Bradley Hospital
🇺🇸Riverside, Rhode Island, United States