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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be over the age of 18 and have been approved and consented for MRgFUS thalamotomy for medication-refractory essential tremor

• Subjects must be and willing to give consent and able to attend all study visits and MRgFUS procedure, understanding the associated risks and benefits.

• Participants must be willing or able to complete questionnaires or have someone who can complete them on their behalf.

Locations
Other Locations
Canada
Sunnybrook Health Sciences
RECRUITING
North York
Contact Information
Primary
Leila Harwood
leila.harwood@sunnybrook.ca
4167796698
Backup
Nadia Scantlebury, PhD
leila.harwood@sunnybrook.ca
4164806100
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2027-03
Participants
Target number of participants: 60
Treatments
Experimental: Exposure to Video number 1
Each participant will be randomized to watch Video number 1, 6-minute VR video associated with the study. Participants will be blinded to the type of video. The study will evaluate the impact of the sights and sounds in the video on anxiety levels.
Experimental: Exposure to Video number 2
Each participant will be randomized to watch Video number 2, 6-minute VR video associated with the study. Participants will be blinded to the type of video. The study will evaluate the impact of the sights and sounds in the video on anxiety levels.
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov