TMS for Improving Response Inhibition in Adolescents With OCD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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.

Group Type OTHER

Transcranial Magnetic Stimulation

Intervention Type DEVICE

All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No