Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD

NCT06442527 | Not Yet Recruiting FDA Device

• 1 other identifier: 2000037937
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on the use of Virtual Reality (VR) technology in patients receiving treatment using Transcranial Magnetic Stimulation (TMS) for Obsessive-Compulsive Disorder (OCD)

Conditions

Obsessive-Compulsive Disorder

Keywords

TMS; Transcranial Magnetic Stimulation; Virtual Reality; VR

Outcome Measures

Primary Outcomes (1)

• Tolerability of VR treatment by qualitative assessment

  Tolerability will be assessed by open-ended interview of the patient about their experience and any difficulty tolerating VR

  Within 1 hour after each treatment session

Study Arms (1)

Treatment Group

EXPERIMENTAL

This single arm will include all participants of the study, who will all receive the intervention

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Virtual reality gear and content will be used prior to TMS session as part of the provocation items

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 18 years old
• Patients must have been clinically evaluated by a Yale Interventional Psychiatry Service physician who has deemed them appropriate to receive TMS for the treatment of OCD
• Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

You may not qualify if:

• Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
• Difficulty in understanding spoken or written English
• Pregnancy
• History of seizure disorder
• Unable to provide informed consent
• Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
• Any implanted medical device, risk of interference with which by the VR device in the investigator's judgment can put patient at additional undue risk.
• Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
• Was previously enrolled/randomized into the study

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sina Nikayin, MD

  Assistant Professor, Departement of Psychiatry, Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Ansari

CONTACT

2036889719; mina.ansari@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)