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

NCT ID: NCT06442527

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

Interventions

Virtual Reality

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sina Nikayin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Departement of Psychiatry, Yale University

Locations

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Mina Ansari

Role: CONTACT

mina.ansari@yale.edu

2036889719

Other Identifiers

2000037937

Identifier Type: -

Identifier Source: org_study_id