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TMS for Improving Response Inhibition in Adolescents With OCD

B

Bradley Hospital

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05104697
5P20GM130452 (U.S. NIH Grant/Contract)
1697181

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

7 participants in 2 patient groups

TMS at visit 1, Sham at visit 2
Other group
Description:
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.
Treatment:
Device: Transcranial Magnetic Stimulation
Sham at visit 1, TMS at visit 2
Other group
Description:
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.
Treatment:
Device: Transcranial Magnetic Stimulation

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Kristen Benito, PhD

Data sourced from clinicaltrials.gov

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