Clinical trial NCT05104697: TMS for Improving Response Inhibition in Adolescents With OCD
Official title: TMS for Improving Response Inhibition in Adolescents With OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: Butler Hospital
name: University of Minnesota
First posted: 2021-11-03
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Response Time on Stop Trials of the Stop Signal Task
timeFrame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
measure: Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
timeFrame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Secondary outcomes:
measure: Self-report Symptom Question
timeFrame: post (within 1 hour after) intervention
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Emma Pendleton Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Bradley Hospital
name: Kristen Benito, PhD
role: PRINCIPAL_INVESTIGATOR
References: