RecruitingNot ApplicableNCT07287605

Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

60 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this randomized study is to evaluate the effect of a virtual reality (VR) video on pre-treatment anxiety levels in individuals undergoing magnetic resonance-guided focused ultrasound (MRgFUS) treatment for medication-refractory essential tremor (ET). Participants will be randomized to view one of two VR videos, and pre-treatment anxiety levels will be compared between groups. As a secondary objective, the study will compare patient concerns (including claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified during the study) between the two randomized groups.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether virtual reality (VR) can improve mood, reduce anxiety, and make the experience less stressful for patients undergoing MRI-guided focused ultrasound (MRgFUS) — a non-invasive brain procedure that uses sound waves to treat essential tremor that no longer responds to medication. **You may be eligible if...** - You are over 18 years old - You have already been evaluated, approved, and scheduled to undergo MRgFUS thalamotomy for essential tremor that does not respond to medication - You are willing and able to complete mood and anxiety questionnaires at several time points (or have someone complete them on your behalf) - You are able to attend all study visits and the MRgFUS procedure **You may NOT be eligible if...** - You are prone to epileptic seizures - You have sensory sensitivities that would make wearing a VR headset during the procedure problematic - You have already undergone a previous MRgFUS procedure (on either side of the brain) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVR headset: video number 1

A 6-minute virtual reality (VR) video that contains sights and sounds that might affect mood. The video is viewed on a Meta Quest 2 (128GB) VR headset with Touch Controllers. Standard preoperative care is provided to all participants.

DEVICEVR headset: video number 2

A 6-minute virtual reality (VR) video that contains sights and sounds that might affect mood. The video is viewed on a Meta Quest 2 (128GB) VR headset with Touch Controllers. Standard preoperative care is provided to all participants.


Locations(1)

Sunnybrook Health Sciences

North York, Ontario, Canada

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NCT07287605


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