NCT04279912

MR-Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis

A Feasibility and Safety Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive MS). This study will be conducted at the Focused Ultrasound Centre of Excellence and MS Clinic located at Sunnybrook Health Sciences Centre/ University of Toronto. Patients with stable MS and refractory hand tremor providing informed consent will receive MRgFUS thermal ablation of the Vim thalamus contralateral to the most affected side of the body (frequently this will be the dominant hand).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis	The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-03-01
• Completion: 2021-07-01
• First posted: 2020-02-21
• Last updated: 2020-02-21

Locations

1 site across 1 country: Canada