A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
- Conditions
- Essential Tremor
- Interventions
- Device: MRgFUS treatment
- Registration Number
- NCT03253991
- Lead Sponsor
- InSightec
- Brief Summary
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET).
The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.
- Detailed Description
The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment.
• This study is designed as a prospective, multi-site, single-arm study. Assessments of primary efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief. Safety of ExAblate in the treatment of ET will be collected for one year after ExAblate treatment. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.
The secondary endpoints of the study are as follows:
1. Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline
2. Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up
3. Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 154
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRgFUS treatment MRgFUS treatment MRgFUS device treatment, thalamotomy
- Primary Outcome Measures
Name Time Method Safety - Will be determined evaluating incidence and severity of device related complications from first treatment day visit through all follow ups. Relative Safety will be evaluated describing Significant Clinical Complications for patients treated. 1 year All AEs will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.
Effectiveness - Will be evaluated using the Clinical Rating Scale for Tremors (CRST) for ET subjects. Comparison will be performed from examinations at baseline and 3-Months post-ExAblate treatment. 5 Years Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan
Department of Neurosurgery, Osaka University Hospital
🇯🇵Osaka, Japan
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Japan
Sadamoto Hospital
🇯🇵Ehime, Japan
Hokkaido Ohno Memorial Hospital
🇯🇵Hokkaido, Japan
Hokuto
🇯🇵Hokkaido, Japan
Kumagaya General Hospital
🇯🇵Kumagaya, Japan
Ohanishi Noerological Center
🇯🇵Hyōgo, Japan
Chang Bing Show Chwan Memorial Hospital
🇨🇳Chang Hua, Taiwan