Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Neurocircuitry of OCD: Effects Of Modulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02704117
• Other study ID #: P50MH106435
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: February 2024

Study information

• Verified date: December 2023
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: February 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Current primary OCD diagnosis and current Y-BOCS total score of =16

• 18-70 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Transcranial Magentic Stimulation
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

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Butler Hospital	Harvard University, University of Pittsburgh, University of Puerto Rico, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)		Baseline and 6 months

External Links

•   Related Info