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Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
sham rTMS
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: OCD group

  • current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and
  • right-handed.

Inclusion Criteria: Healthy Control group

  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • right-handed.

Exclusion Criteria: OCD group

  • active problematic substance use;
  • lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature;
  • clinically significant hoarding symptoms;
  • active suicidal or homicidal ideation;
  • significant neurological disease or intracranial pathology;
  • use of medications which increase risk for seizures during TMS;
  • significant or unstable medical disorders or contraindication to TMS or MRI scan.

Exclusion Criteria: Healthy Control group

  • current psychiatric diagnosis;
  • lifetime psychosis, bipolar mood disorder, or OCD;
  • active suicidal or homicidal ideation;
  • significant neurological disease or intracranial pathology;
  • use of psychiatric medications;
  • use of medications which increase risk for seizures during TMS;
  • significant or unstable medical disorders or contraindication to TMS or MRI scan.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Sham Comparator

Other

Other

Other

Other

Other

Arm Label

OCD, Active TMS

OCD, Sham TMS

Healthy Control, Active TMS

Healthy Control, Sham TMS

Healthy Control, Active TMS (1 session)

Healthy Control, Active TMS (3 sessions)

OCD, Active TMS (3 session)

Arm Description

Participants with OCD who receive active rTMS

Participants with OCD who receive sham rTMS

Healthy control participants who receive active rTMS

Healthy control participants who receive sham rTMS

Healthy control participants who receive 1 session of active, open-label rTMS

Healthy control participants who receive 3 sessions of active, open-label rTMS

Participants with OCD who receive 3 sessions of active, open-label rTMS

Outcomes

Primary Outcome Measures

Resting-state functional connectivity with ventral striatum
Resting-state functional connectivity with ventral striatum (assessed via fMRI)
Resting-state functional connectivity with dorsal striatum
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Cognitive flexibility task performance
Behavioral performance on a cognitive flexibility task (% trials correct)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2019
Last Updated
December 9, 2022
Sponsor
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04165577
Brief Title
Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
Official Title
Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.

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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Arms denoted as open-label do not include masking
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCD, Active TMS
Arm Type
Experimental
Arm Description
Participants with OCD who receive active rTMS
Arm Title
OCD, Sham TMS
Arm Type
Sham Comparator
Arm Description
Participants with OCD who receive sham rTMS
Arm Title
Healthy Control, Active TMS
Arm Type
Other
Arm Description
Healthy control participants who receive active rTMS
Arm Title
Healthy Control, Sham TMS
Arm Type
Other
Arm Description
Healthy control participants who receive sham rTMS
Arm Title
Healthy Control, Active TMS (1 session)
Arm Type
Other
Arm Description
Healthy control participants who receive 1 session of active, open-label rTMS
Arm Title
Healthy Control, Active TMS (3 sessions)
Arm Type
Other
Arm Description
Healthy control participants who receive 3 sessions of active, open-label rTMS
Arm Title
OCD, Active TMS (3 session)
Arm Type
Other
Arm Description
Participants with OCD who receive 3 sessions of active, open-label rTMS
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
1-Hz rTMS targeting frontal pole
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
sham rTMS targeting frontal pole
Primary Outcome Measure Information:
Title
Resting-state functional connectivity with ventral striatum
Description
Resting-state functional connectivity with ventral striatum (assessed via fMRI)
Time Frame
Before rTMS and approximately 1 day following open-label rTMS
Title
Resting-state functional connectivity with dorsal striatum
Description
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Time Frame
Before rTMS and approximately 1 day following open-label rTMS
Title
Cognitive flexibility task performance
Description
Behavioral performance on a cognitive flexibility task (% trials correct)
Time Frame
Before rTMS and approximately 1 day following open-label rTMS
Other Pre-specified Outcome Measures:
Title
Change in regional activation in orbitofrontal cortex
Description
Change in task-based regional activation (assessed via functional magnetic resonance imaging; fMRI) in orbitofrontal cortex
Time Frame
Before rTMS and within 30 minutes immediately following rTMS
Title
Change in regional activation in dorsolateral prefrontal cortex
Description
Change in task-based regional activation (assessed via fMRI) in dorsolateral prefrontal cortex
Time Frame
Before rTMS and within 30 minutes immediately following rTMS
Title
Change in regional activation in anterior cingulate cortex
Description
Change in task-based regional activation (assessed via fMRI) in anterior cingulate cortex
Time Frame
Before rTMS and within 30 minutes immediately following rTMS
Title
Resting-state functional connectivity with ventral striatum
Description
Resting-state functional connectivity with ventral striatum (assessed via fMRI)
Time Frame
Before rTMS and within 30 minutes immediately following rTMS
Title
Resting-state functional connectivity with dorsal striatum
Description
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Time Frame
Before rTMS and within 30 minutes immediately following rTMS
Title
Cognitive flexibility task performance
Description
Behavioral performance on a cognitive flexibility task (% trials correct)
Time Frame
Before rTMS and within 30 minutes immediately following rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: OCD group current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16; 18-55 years of age; ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent; either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and right-handed. Inclusion Criteria: Healthy Control group 18-55 years of age; ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent; right-handed. Exclusion Criteria: OCD group active problematic substance use; lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature; clinically significant hoarding symptoms; active suicidal or homicidal ideation; significant neurological disease or intracranial pathology; use of medications which increase risk for seizures during TMS; significant or unstable medical disorders or contraindication to TMS or MRI scan. Exclusion Criteria: Healthy Control group current psychiatric diagnosis; lifetime psychosis, bipolar mood disorder, or OCD; active suicidal or homicidal ideation; significant neurological disease or intracranial pathology; use of psychiatric medications; use of medications which increase risk for seizures during TMS; significant or unstable medical disorders or contraindication to TMS or MRI scan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Garnaat, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study

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