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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Sunnybrook Health Sciences
  North York, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Jennifer Rabin, PhD, C.Psych — Sunnybrook
• Study coordinator: Leila Harwood
• Email: leila.harwood@sunnybrook.ca
• Phone: 4167796698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.