Actively Recruiting
Bilateral Essential Tremor Treatment With Gamma Knife
Led by Université de Sherbrooke · Updated on 2021-11-17
50
Participants Needed
2
Research Sites
277 weeks
Total Duration
On this page
Sponsors
U
Université de Sherbrooke
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with essential tremor who previously underwent successful and uncomplicated GK thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed at baseline, as well as 3, 6, 12, 24 and 36 months post-operatively.
CONDITIONS
Official Title
Bilateral Essential Tremor Treatment With Gamma Knife
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older
- Primary diagnosis of essential tremor or essential tremor plus confirmed by a movement disorder neurologist
- Previous Gamma Knife thalamotomy performed more than 12 months ago
- Tremor on the untreated side negatively impacts quality of life
- Patient desires treatment of the contralateral side
You will not qualify if you...
- Significant gait or balance problems such as wide-based walking, more than 2 falls per month, or use of wheelchair, walker, or cane
- Significant speech impairment affecting intelligibility
- Inability to follow the study's follow-up schedule
- Refusal by the treating physician to allow participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
2
CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Actively Recruiting
Research Team
C
Christian Iorio-Morin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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