Status:
ACTIVE_NOT_RECRUITING
Bilateral Essential Tremor Treatment With FUS
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Université de Sherbrooke
Conditions:
Essential Tremor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will under...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years
- The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist;
- The patient previously underwent a MRgFUS (\> 6 months ago);
- The tremor on the untreated side negatively impacts the patients' quality of life;
- The patient wants treatment of the contralateral side.
Exclusion
- Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)
- Clinically relevant speech impairment (e.g. impairment of intelligibility)
- Inability to comply with the follow-up schedule;
- Refusal of the treating physician.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04501484
Start Date
July 8 2020
End Date
December 1 2025
Last Update
May 8 2024
Active Locations (1)
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1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8