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
34 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
Researchers are evaluating the use of Gamma Knife thalamotomy for patients with essential tremor who have already undergone successful treatment on one side of the brain. This combined Phase II/III multicenter trial aims to study the effects and safety of treating the opposite side to improve quality of life. The trial will assess changes in tremor impact and patient health over time, with particular focus on side effects and functional outcomes. Participants will receive a contralateral thalamotomy using a frame-based Gamma Knife Perfexion or Icon system. The initial Phase II portion involves 10 patients, with plans to expand to Phase III by enrolling 40 more after safety review. Treatments target the VIM nucleus of the thalamus, and patients will be monitored at multiple intervals including 3, 6, 12, 24, and 36 months after the procedure. During the study, participants will undergo evaluations of tremor severity, gait, speech, and quality of life through filmed assessments and questionnaires. Safety monitoring includes grading side effects per established criteria. The primary outcomes focus on changes in quality of life (QUEST score) and patient-reported health utility at 12 months. Secondary outcomes include objective measures of tremor, gait, speech, adverse events, and long-term follow-up to 36 months after treatment.
CONDITIONS
Brief 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
- Confirmed diagnosis of essential tremor or essential tremor plus by a movement disorder neurologist
- Previous Gamma Knife thalamotomy performed more than 12 months ago
- Tremor on the untreated side negatively affects quality of life
- Patient desires treatment on the opposite 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 required follow-up schedule
- Refusal by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with recovery period
Participants undergo a Gamma Knife VIM thalamotomy procedure to treat essential tremor on the untreated side.
1 treatment visit (in-person)
Duration - Up to 36 months post treatment
Participants are monitored through regular assessments to evaluate gait, speech, tremor, quality of life, and adverse events after the treatment.
Visits at baseline and post-operative months 3, 6, 12, 24, and 36 (in-person)
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
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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