Trials / Active Not Recruiting
Active Not RecruitingNCT04112381
Bilateral Treatment of Medication Refractory Essential Tremor
A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- InSightec · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Exablate Model 4000 Type 1.0/1.1 | Exablate thalamotomy of non tremor dominant side of the brain |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2026-03-01
- Completion
- 2026-06-01
- First posted
- 2019-10-02
- Last updated
- 2025-05-01
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04112381. Inclusion in this directory is not an endorsement.