Virtual reality to reduce anxiety before MR-guided focused ultrasound for essential tremor

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

This study tests whether watching a short virtual reality video can lower pre-treatment anxiety in adults having MRgFUS for medication-refractory essential tremor.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Locations: 1 site (North York, Ontario)
• Trial ID: NCT07287605 on ClinicalTrials.gov

What this trial studies

Sixty adults scheduled for MR-guided focused ultrasound (MRgFUS) for medication-refractory essential tremor will be randomized to view one of two 6-minute immersive virtual reality procedural videos using a headset immediately prior to treatment. Preoperative anxiety will be measured with validated self-report tools including the Visual Analogue Scale for Anxiety (VAS), the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and the State-Trait Anxiety Inventory - State version (STAI-S). The primary comparison is pre-treatment anxiety between the two VR video groups, and secondary analyses will compare specific patient concerns such as claustrophobia, mental preparedness, and fear of pain, plus any additional concerns reported by participants. All procedures and VR exposures occur in person at the MRgFUS visit prior to the therapeutic procedure.

Who should consider this trial

Good fit: Adults (18+) who have been approved and consented for MRgFUS thalamotomy for medication-refractory essential tremor, can use a VR headset, and can complete questionnaires (or have someone do so on their behalf) are ideal candidates.

Not a fit: Patients with a history of epileptic seizures or sensory issues (who are excluded), those who have previously had MRgFUS, or individuals whose anxiety is not responsive to VR may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the VR intervention could reduce pre-treatment anxiety and make the MRgFUS experience more comfortable for patients.

How similar studies have performed: Previous VR interventions have reduced preoperative anxiety in other surgical and imaging settings, but applying VR specifically for MRgFUS in essential tremor is a novel application.

Eligibility criteria

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 this trial is running

North York, Ontario

• Sunnybrook Health Sciences — North York, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Dr. Jennifer Rabin, PhD, C.Psych — Sunnybrook
• Study coordinator: Leila Harwood

Conditions: Preoperative Anxiety, medication-refractory essential tremor, focused ultrasound, virtual reality intervention, MRgFUS, preoperative anxiety