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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06442527
Other study ID # 2000037937
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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