Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
Recruiting · NCT07287605 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Patients prone to epileptic seizures and/or sensory issues will be excluded from the study.
- Patients who have previously undergone an MRgFUS procedure (ipsilateral or contralateral to the hemisphere currently being treated) will be excluded.
Where it is running
1 location listed.
- Sunnybrook Health Sciences - North York, Ontario, Canada