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International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS
This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.
Details
| Lead sponsor | InSightec |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 100 |
| Start date | 2025-04-22 |
| Completion | 2028-01 |
Conditions
- Essential Tremor
Interventions
- Staged bilateral Exablate thalamotomy
- Local standard medical treatment after previous Exablate unilateral thalamotomy.
Primary outcomes
- Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side. — 6 Months
The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor.
Countries
Finland, Germany, Italy, Spain, United Kingdom