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

Obsessive-Compulsive Disorder Clinical Trial

— VR-TMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442527
• Other study ID #: 2000037937
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Mina Ansari
• Phone: 2036889719
• Email: mina.ansari[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: October 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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