A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
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|ClinicalTrials.gov Identifier: NCT03253991|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : November 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: MRgFUS treatment||Not Applicable|
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:
- Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline
- 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
- Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective multi-site, single-arm study|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects|
|Actual Study Start Date :||November 17, 2014|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: MRgFUS treatment
MRgFUS device treatment, thalamotomy
Device: MRgFUS treatment
ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Other Name: Thalamotomy
- 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. [ Time Frame: 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. [ Time Frame: 5 Years ]Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253991
|Contact: Martin Bernstein||972542584126||martinb@Insightec.com|
|Contact: Masatsugu Okamoto||+81-42-649-9761||masatsuguo@Insightec.com|
|China, Haidian District Of Beijing|
|Chinese PLA General Hospital||Not yet recruiting|
|Beijing, Haidian District Of Beijing, China|
|Contact: Rui Zong, MD 13810094888 email@example.com|
|Principal Investigator: Pan Longsheng, Professor|
|Sadamoto Hospital||Active, not recruiting|
|Ehime, Japan, 790-0052|
|Shonan Fujisawa Tokushukai Hospital||Active, not recruiting|
|Fujisawa, Japan, 2510041|
|Hokkaido Ohno Memorial Hospital||Recruiting|
|Hokkaido, Japan, 063-0052|
|Contact: Yuzo Terakawa +81-11-665-0020 firstname.lastname@example.org|
|Hokuto||Active, not recruiting|
|Hokkaido, Japan, 080-0833|
|Ohanishi Noerological Center||Active, not recruiting|
|Hyōgo, Japan, 6740064|
|Kumagaya General Hospital||Active, not recruiting|
|Kumagaya, Japan, 360-8567|
|Department of Neurosurgery, Osaka University Hospital||Active, not recruiting|
|Osaka, Japan, 565-0871|
|Tokyo Women's Medical University Hospital||Active, not recruiting|
|Tokyo, Japan, 62-8666|
|Chang Bing Show Chwan Memorial Hospital||Active, not recruiting|
|Chang Hua, Taiwan, 505|