ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01772693|
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.
Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: ExAblate Transcranial MRgFUS Device: Sham ExAblate Transcranial MRgFUS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single factor. ExAblate test verses ExAblate placebo randomized 2:1.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 26, 2016|
|Actual Study Completion Date :||March 2019|
Experimental: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR guided Focused Ultrasound
Device: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR Guided Focused Ultrasound
Sham Comparator: Sham ExAblate Transcranial MRgFUS
Sham treatment with ExAblate MR guided Focused Ultrasound
Device: Sham ExAblate Transcranial MRgFUS
Sham ExAblate Transcranial MR Guided Focused Ultrasound
- Number of Adverse Events [ Time Frame: Month 3 ]
Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.
Primary safety analyses are reported in the adverse events module.
- Tremor Motor Score Percent Change From Baseline. [ Time Frame: Baseline, Month 3 ]The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).
- Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B. [ Time Frame: Baseline, Month 3, Month 12 ]Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
- Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities [ Time Frame: Baseline, Month 3, Month 12 ]The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.
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): NCT01772693
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Jeff Elias, M.D.||University of Virginia|