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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772693
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Device: ExAblate Transcranial MRgFUS
Device: Sham ExAblate Transcranial MRgFUS
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Period Title: Overall Study
Started 20 7
Completed 14 6
Not Completed 6 1
Reason Not Completed
Health Concerns Unrelated to Study             2             1
Withdrawal by Subject             2             0
Alternative Treatment             2             0
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS Total
Hide Arm/Group Description

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Total of all reporting groups
Overall Number of Baseline Participants 20 7 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 7 participants 27 participants
67.9  (9.6) 62.9  (11.3) 66.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 7 participants 27 participants
Female
1
   5.0%
0
   0.0%
1
   3.7%
Male
19
  95.0%
7
 100.0%
26
  96.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants 7 participants 27 participants
Caucasian
18
  90.0%
6
  85.7%
24
  88.9%
Black
2
  10.0%
0
   0.0%
2
   7.4%
Other
0
   0.0%
1
  14.3%
1
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 7 participants 27 participants
20 7 27
Clinical Rating Scale for Tremor - Treated Side   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 7 participants 27 participants
19.0  (8.7) 20.1  (7.4) 19.3  (8.3)
[1]
Measure Description: 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 Unified Parkinson's Disease Rating Scale (UPDRS) #20   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 7 participants 27 participants
3.7  (1.0) 3.4  (1.5) 3.6  (1.1)
[1]
Measure Description: 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 Unified Parkinson's Disease Rating Scale (UPDRS) #21   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 7 participants 27 participants
3.2  (1.3) 3.6  (1.1) 3.3  (1.2)
[1]
Measure Description: 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.
1.Primary Outcome
Title Number of Adverse Events
Hide Description

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.

Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Adverse Events are reported in the Adverse Events module.
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description:

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Overall Number of Participants Analyzed 20 7
Measure Type: Number
Unit of Measure: Number of Adverse Events
100 10
2.Secondary Outcome
Title Tremor Motor Score Percent Change From Baseline.
Hide Description 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).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description:

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Overall Number of Participants Analyzed 20 7
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
51.9  (33.4) 12.7  (25.7)
3.Secondary Outcome
Title Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.
Hide Description 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.
Time Frame Baseline, Month 3, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description:

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Overall Number of Participants Analyzed 20 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 19.0  (8.7) 20.1  (7.4)
Month 3 9.6  (9.7) 17.4  (7.8)
Month 12 10.5  (10.2) NA [1]   (NA)
[1]
The sham ExAblate subjects exited the study at Month 3. The Exablate test subjects continued through Month 12.
4.Secondary Outcome
Title Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities
Hide Description 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.
Time Frame Baseline, Month 3, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Exablate sham subjects exited the study at the Month 3 visit. The Exablate test subjects continued on through Month 12.
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description:

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

Overall Number of Participants Analyzed 20 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 14.1  (5.7) 16.7  (3.9)
Month 3 6.4  (6.6) 14.6  (4.2)
Month 12 6.9  (7.2) NA [1]   (NA)
[1]
The Exablate sham subjects exited the study at the Month 3 study visit.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Hide Arm/Group Description

ExAblate Transcranial MR guided Focused Ultrasound

ExAblate Transcranial MRgFUS: ExAblate Transcranial MR Guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS: Sham ExAblate Transcranial MR Guided Focused Ultrasound

All-Cause Mortality
ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/20 (15.00%)      1/7 (14.29%)    
Gastrointestinal disorders     
Cholecystitis * [1]  1/20 (5.00%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Degenerative knee disease * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Nervous system disorders     
Hemiparesis * [3]  2/20 (10.00%)  2 0/7 (0.00%)  0
Ataxia * [4]  1/20 (5.00%)  1 0/7 (0.00%)  0
Psychiatric disorders     
Worsening depression * [5]  1/20 (5.00%)  1 0/7 (0.00%)  0
Vascular disorders     
Transient ischemic attack * [6]  0/20 (0.00%)  0 1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated to device or procedure
[2]
Unrelated to device or procedure. Subject had knee replacement and physical therapy. Adverse event resolved.
[3]
After Focused Ultrasound Surgery thalamotomy procedure. Determined event to be SAE related to thalamotomy.
[4]
Event 1 component was mild right-sided hemiparesis (weakness) with drift. Event expected and related to thalamotomy. Resolved.
[5]
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.
[6]
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.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ExAblate Transcranial MRgFUS Sham ExAblate Transcranial MRgFUS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      5/7 (71.43%)    
Ear and labyrinth disorders     
Dizziness * [1]  1/20 (5.00%)  1 1/7 (14.29%)  1
Dizziness * [2]  7/20 (35.00%)  7 0/7 (0.00%)  0
Dizziness * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Eye disorders     
Visual field defect * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Pigment change in eye * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Vision change * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Nausea/Vomiting * [2]  5/20 (25.00%)  5 1/7 (14.29%)  1
Cholecystitis * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Stomach pain * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
General disorders     
Sleep Disorder * [4]  1/20 (5.00%)  1 0/7 (0.00%)  0
Fatique * [1]  2/20 (10.00%)  2 0/7 (0.00%)  0
Headache * [2]  11/20 (55.00%)  11 2/7 (28.57%)  2
Sonication related head pain * [2]  5/20 (25.00%)  6 1/7 (14.29%)  1
Vocal change * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal weakness * [1]  1/20 (5.00%)  1 0/7 (0.00%)  0
Dysmetria * [5]  1/20 (5.00%)  1 0/7 (0.00%)  0
Gait disturbance * [5]  2/20 (10.00%)  2 0/7 (0.00%)  0
Hemiparesis * 1  2/20 (10.00%)  2 0/7 (0.00%)  0
Imbalance * [5]  4/20 (20.00%)  4 0/7 (0.00%)  0
Imbalance * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Positional pain * [2]  3/20 (15.00%)  3 0/7 (0.00%)  0
Musculoskeletal weakness * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Musculoskeletal pain * [3]  1/20 (5.00%)  2 0/7 (0.00%)  0
Positional pain * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Nervous system disorders     
Dysgnosia * [6]  0/20 (0.00%)  0 1/7 (14.29%)  1
Tremor worsened * [6]  1/20 (5.00%)  1 0/7 (0.00%)  0
Dysgnosia * [1]  1/20 (5.00%)  1 0/7 (0.00%)  0
Dysmetria * [5]  2/20 (10.00%)  2 0/7 (0.00%)  0
Ataxia * [5]  2/20 (10.00%)  2 0/7 (0.00%)  0
Numbness/tingling * [5]  7/20 (35.00%)  8 0/7 (0.00%)  0
Unsteady * [5]  1/20 (5.00%)  1 0/7 (0.00%)  0
Imbalance * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Numbness/tingling * [2]  5/20 (25.00%)  7 0/7 (0.00%)  0
Psychiatric disorders     
Anxiety * [2]  2/20 (10.00%)  2 0/7 (0.00%)  0
Dysgnosia * [2]  2/20 (10.00%)  2 0/7 (0.00%)  0
Worsening depression * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Sonication related flushing * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Sonication related scalp pain * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Pin Site Pain * [2]  0/20 (0.00%)  0 1/7 (14.29%)  1
Facial edema * [3]  3/20 (15.00%)  3 0/7 (0.00%)  0
Pin site numbness/tingling * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Pin site pain * [3]  3/20 (15.00%)  3 1/7 (14.29%)  1
Stereotactic frame bruising * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Vascular disorders     
Hypertension * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Syncope * [2]  1/20 (5.00%)  1 0/7 (0.00%)  0
Cerebelar infarct * [3]  1/20 (5.00%)  1 0/7 (0.00%)  0
Transient Ischemic Attack * [3]  0/20 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, Thalamotomy related
*
Indicates events were collected by non-systematic assessment
[1]
Procedure related
[2]
Transient
[3]
Unrelated
[4]
Related to Parkinson's Disease progression.
[5]
Thalamotomy related
[6]
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nadir Alikacem, Ph.D., VP Clinical Research
Organization: Insightec
Phone: 214-630-2000
EMail: nadira@insightec.com
Layout table for additonal information
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01772693    
Other Study ID Numbers: PD001
First Submitted: November 28, 2012
First Posted: January 21, 2013
Results First Submitted: July 23, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020