- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01772693
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women, age 30 years and older
- Subjects who are able and willing to give informed consent and able to attend all study visits
- Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
- Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
- Subject exhibits a significant disability from their PD tremor despite medical treatment
- Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
- Subject is able to communicate sensations during the ExAblate Transcranial procedure
Exclusion Criteria:
- Subjects with unstable cardiac status
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- Severe hypertension
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
- Significant claustrophobia that cannot be managed with mild medication
- Current medical condition resulting in abnormal bleeding and/or coagulopathy
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
- History of intracranial hemorrhage
- History of multiple strokes, or a stroke within past 6 months
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Subjects unable to communicate with the investigator and staff
- Subjects with a history of seizures within the past year
- Subjects with brain tumors
- Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR guided Focused Ultrasound
|
ExAblate Transcranial MR Guided Focused Ultrasound
Other Names:
|
Sham Comparator: Sham ExAblate Transcranial MRgFUS
Sham treatment with ExAblate MR guided Focused Ultrasound
|
Sham ExAblate Transcranial MR Guided Focused Ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, Month 3
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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.
|
Baseline, Month 3, Month 12
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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.
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Baseline, Month 3, Month 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeff Elias, M.D., University of Virginia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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