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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.
Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExAblate Transcranial MRgFUS | Experimental | ExAblate Transcranial MR guided Focused Ultrasound |
|
| Sham ExAblate Transcranial MRgFUS | Sham Comparator | Sham treatment with ExAblate MR guided Focused Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExAblate Transcranial MRgFUS | Device | ExAblate Transcranial MR Guided Focused Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Motor Score Percent Change From Baseline. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Elias, M.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States | ||
| Swedish Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29084313 | Derived | Bond AE, Shah BB, Huss DS, Dallapiazza RF, Warren A, Harrison MB, Sperling SA, Wang XQ, Gwinn R, Witt J, Ro S, Elias WJ. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Dec 1;74(12):1412-1418. doi: 10.1001/jamaneurol.2017.3098. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ExAblate Transcranial MRgFUS | ExAblate Transcranial MR guided Focused Ultrasound ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound |
| FG001 | Sham ExAblate Transcranial MRgFUS | Sham treatment with ExAblate MR guided Focused Ultrasound Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ExAblate Transcranial MRgFUS | ExAblate Transcranial MR guided Focused Ultrasound ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound |
| BG001 | Sham ExAblate Transcranial MRgFUS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | 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. | All Adverse Events are reported in the Adverse Events module. | Posted | Number | Number of Adverse Events | Month 3 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ExAblate Transcranial MRgFUS | ExAblate Transcranial MR guided Focused Ultrasound ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemiparesis | Nervous system disorders | Non-systematic Assessment | After Focused Ultrasound Surgery thalamotomy procedure. Determined event to be SAE related to thalamotomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleep Disorder | General disorders | Non-systematic Assessment | Related to Parkinson's Disease progression. |
This is a feasibility trial with no pre-defined hypothesis testing. It is primarily a safety trial with a secondary objective of collecting efficacy outcomes for developing future pivotal trials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadir Alikacem, Ph.D., VP Clinical Research | Insightec | 214-630-2000 | nadira@insightec.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single factor. ExAblate test verses ExAblate placebo randomized 2:1.
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| Sham ExAblate Transcranial MRgFUS | Device | Sham ExAblate Transcranial MR Guided Focused Ultrasound |
|
| Baseline, Month 3 |
| Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B. | 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 |
| Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities | 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. | Baseline, Month 3, Month 12 |
| Seattle |
| Washington |
| 98122 |
| United States |
| Alternative Treatment |
|
Sham treatment with ExAblate MR guided Focused Ultrasound
Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinical Rating Scale for Tremor - Treated Side | Baseline sum of upper extremity Tremor-Motor scores for the treated side from the Clinical Rating Scale for Tremor (CRST) Part A and Part B averaged across subjects. This measure of upper extremity tremor ranges from 0-32 with high scores being worse. | Mean | Standard Deviation | units on a scale |
|
| Mean Unified Parkinson's Disease Rating Scale (UPDRS) #20 | The Unified Parkinson's Disease Rating Scale (UPDRS) Question 20 is a measure of tremor of the treated side hand at rest on a score from 0 to 4 points. High scores are worse. Scores are averaged across subjects. | Mean | Standard Deviation | units on a scale |
|
| Mean Unified Parkinson's Disease Rating Scale (UPDRS) #21 | The Unified Parkinson's Disease Rating Scale (UPDRS) Question 21 is an assessment of action or postural tremor of the treated side hand scored from 0 to 4. High scores are worse. The scores are averaged across subjects. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Tremor Motor Score Percent Change From Baseline. | 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). | Posted | Mean | Standard Deviation | percent change from baseline | Baseline, Month 3 |
|
|
|
| Secondary | Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 12 |
|
|
|
| Secondary | Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities | 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. | The Exablate sham subjects exited the study at the Month 3 visit. The Exablate test subjects continued on through Month 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, Month 12 |
|
|
|
| 0 |
| 20 |
| 3 |
| 20 |
| 20 |
| 20 |
| EG001 | Sham ExAblate Transcranial MRgFUS | Sham treatment with ExAblate MR guided Focused Ultrasound Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound | 0 | 7 | 1 | 7 | 5 | 7 |
|
| Ataxia | Nervous system disorders | Non-systematic Assessment | Event 1 component was mild right-sided hemiparesis (weakness) with drift. Event expected and related to thalamotomy. Resolved. |
|
| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment | Unrelated to device or procedure |
|
| Degenerative knee disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device or procedure. Subject had knee replacement and physical therapy. Adverse event resolved. |
|
| Worsening depression | Psychiatric disorders | Non-systematic Assessment | Since his tremor was gone he stopped his dopamine antagonist and he also stopped his antidepressants. His physicians planned to re-instate antidepressant medications and neuropsychology treatment. |
|
| Transient ischemic attack | Vascular disorders | Non-systematic Assessment | The Data Safety Monitoring Board discussed the event, the subject's symptoms and the lack of imaging findings and determined that they agreed with the investigator that this event was Unrelated to the Exablate procedure. |
|
|
| Dysgnosia | Nervous system disorders | Non-systematic Assessment | Related to Parkinson's Disease progression |
|
| Tremor worsened | Nervous system disorders | Non-systematic Assessment | Related to Parkinson's Disease progression |
|
| Fatique | General disorders | Non-systematic Assessment | Procedure related |
|
| Musculoskeletal weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Procedure related |
|
| Dysgnosia | Nervous system disorders | Non-systematic Assessment | Procedure related |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Procedure related |
|
| Dysmetria | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Thalamotomy related |
|
| Gait disturbance | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Thalamotomy related |
|
| Hemiparesis | Musculoskeletal and connective tissue disorders | Thalamotomy related | Non-systematic Assessment |
|
| Imbalance | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Thalamotomy related |
|
| Dysmetria | Nervous system disorders | Non-systematic Assessment | Thalamotomy related |
|
| Ataxia | Nervous system disorders | Non-systematic Assessment | Thalamotomy related |
|
| Numbness/tingling | Nervous system disorders | Non-systematic Assessment | Thalamotomy related |
|
| Unsteady | Nervous system disorders | Non-systematic Assessment | Thalamotomy related |
|
| Hypertension | Vascular disorders | Non-systematic Assessment | Transient |
|
| Syncope | Vascular disorders | Non-systematic Assessment | Transient |
|
| Sonication related flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient |
|
| Visual field defect | Eye disorders | Non-systematic Assessment | Transient |
|
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Transient |
|
| Imbalance | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Transient |
|
| Positional pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Transient |
|
| Imbalance | Nervous system disorders | Non-systematic Assessment | Transient |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment | Transient |
|
| Dysgnosia | Psychiatric disorders | Non-systematic Assessment | Transient |
|
| Numbness/tingling | Nervous system disorders | Non-systematic Assessment | Transient |
|
| Headache | General disorders | Non-systematic Assessment | Transient |
|
| Sonication related scalp pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient |
|
| Sonication related head pain | General disorders | Non-systematic Assessment | Transient |
|
| Pin Site Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Transient |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Transient |
|
| Pigment change in eye | Eye disorders | Non-systematic Assessment | Unrelated |
|
| Vision change | Eye disorders | Non-systematic Assessment | Unrelated |
|
| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment | Unrelated |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment | Unrelated |
|
| Vocal change | General disorders | Non-systematic Assessment | Unrelated |
|
| Worsening depression | Psychiatric disorders | Non-systematic Assessment | Unrelated |
|
| Musculoskeletal weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated |
|
| Positional pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated |
|
| Cerebelar infarct | Vascular disorders | Non-systematic Assessment | Unrelated |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Unrelated |
|
| Transient Ischemic Attack | Vascular disorders | Non-systematic Assessment | Unrelated |
|
| Facial edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated |
|
| Pin site numbness/tingling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated |
|
| Pin site pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated |
|
| Stereotactic frame bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Month 12 |
|
| Month 12 |
|