NCT02704117

Brief Summary

The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

7.3 years

First QC Date

February 29, 2016

Last Update Submit

December 13, 2023

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)

    Baseline and 6 months

Secondary Outcomes (1)

  • Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Baseline and 6 months

Study Arms (1)

Transcranial Magnetic Stimulation

EXPERIMENTAL

Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.

Device: Transcranial Magentic Stimulation

Interventions

Transcranial Magentic StimulationDEVICE

This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks

Also known as: Continuous Theta Burst Stimulation (cTBS)
Transcranial Magnetic Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current primary OCD diagnosis and current Y-BOCS total score of ≥16
  • years of age
  • Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
  • No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
  • Ongoing psychotherapy allowed if already established for three months or more before study entry

You may not qualify if:

  • History of primary psychotic disorder or bipolar disorder
  • Present acute suicidality
  • History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
  • Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
  • Premorbid intelligence quotient (IQ) estimate \< 80
  • Visual disturbance (\<20/40 Snellen visual acuity, corrected)
  • Current, or alcohol or illicit substance abuse/dependence in the last 3 months
  • Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
  • Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
  • Current psychotic symptoms
  • An increased risk of seizure, determined by history
  • Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (\> 4 mg/day of clonazepam or equivalent)
  • Predominant hoarding symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 9, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2022

Study Completion

February 1, 2024

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

US(1)