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TMS for Improving Response Inhibition in Adolescents With OCD

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Bradley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Emma Pendleton Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TMS at visit 1, Sham at visit 2

Sham at visit 1, TMS at visit 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in response time on stop trials of the stop signal task
Computerized task, where shorter response time (in seconds) indicates better performance
Change in frontocentral P3 amplitude on Electroencephalogram (EEG)
Electroencephalogram (EEG)

Secondary Outcome Measures

3-item self-report symptom questionnaire
self-rated mood and OCD symptoms on a 0-5 scale, where higher scores indicate more symptoms

Full Information

First Posted
October 9, 2021
Last Updated
July 7, 2022
Sponsor
Bradley Hospital
Collaborators
Butler Hospital, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05104697
Brief Title
TMS for Improving Response Inhibition in Adolescents With OCD
Official Title
TMS for Improving Response Inhibition in Adolescents With OCD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bradley Hospital
Collaborators
Butler Hospital, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS at visit 1, Sham at visit 2
Arm Type
Other
Arm 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.
Arm Title
Sham at visit 1, TMS at visit 2
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
Primary Outcome Measure Information:
Title
Change in response time on stop trials of the stop signal task
Description
Computerized task, where shorter response time (in seconds) indicates better performance
Time Frame
Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Title
Change in frontocentral P3 amplitude on Electroencephalogram (EEG)
Description
Electroencephalogram (EEG)
Time Frame
Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Secondary Outcome Measure Information:
Title
3-item self-report symptom questionnaire
Description
self-rated mood and OCD symptoms on a 0-5 scale, where higher scores indicate more symptoms
Time Frame
post (within 1 hour after) intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Benito, PhD
Phone
401-432-1468
Email
kbenito@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Benito, PhD
Organizational Affiliation
Bradley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emma Pendleton Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Benito, PhD
Phone
401-432-1473
Email
kbenito@lifespan.org

12. IPD Sharing Statement

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TMS for Improving Response Inhibition in Adolescents With OCD

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