ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ExAblate Pallidotomy
Sham ExAblate Pallidotomy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring ExAblate, MRgFUS, Pallidotomy
Eligibility Criteria
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 through 12 Months.
- Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
- MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
- Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
- Subject is able to communicate sensations during the ExAblate procedure.
- Subjects on stable antidepressant medications for at least 3 months
Exclusion Criteria:
- Hoehn and Yahr stage in the ON medication state of 3 or greater.
- Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
- Presence of significant cognitive impairment using MMSE ≤ 24.
- Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
- Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP > 100 on 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 (e.g., Avastin) within one month of focused ultrasound procedure.
- Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
- Patient with kidney disease or on dialysis.
- Subjects with standard contraindications for MR imaging
- Significant claustrophobia that cannot be managed with mild medication.
- Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
- History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
- 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.
- Are participating or have participated in another clinical trial in the last 30 days.
Sites / Locations
- Stanford University Medical Center
- Palm Beach Neuroscience Institute/Sperling Medical Group
- University of Maryland Medical System
- Brigham and Women's Hospital
- Mayo Clinic
- New York University Health Langone
- Weill Cornell Medicine
- The Ohio State Wexner Medical Center
- Pennsylvania Hospital Department of Neurosurgery
- University of Virginia Health System
- Swedish Medical Center
- Toronto Western Hospital
- Rambam Health Care
- Fondazione IRCCS Neurological Institute Carlo Besta
- Azienda Ospedaliera Universitaria di Verona, Univerista di Verona
- Severance Hospital, Yonsei University Health System
- CINAC-Hospital HM Puerta del Sur
- Clinica Universidad De Navarra
- Chang Bing Show Chwan Memorial Hospital
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ExAblate Pallidotomy
Sham ExAblate Pallidotomy
Arm Description
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
Sham (fake) treatment
Outcomes
Primary Outcome Measures
Responder Analysis
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
Secondary Outcome Measures
Severity of Device and Procedure related complications
To evaluate of the incidence and severity of device- and procedure-related
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03319485
Brief Title
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
Official Title
A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Detailed Description
The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
ExAblate, MRgFUS, Pallidotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ExAblate Pallidotomy
Arm Type
Experimental
Arm Description
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
Arm Title
Sham ExAblate Pallidotomy
Arm Type
Sham Comparator
Arm Description
Sham (fake) treatment
Intervention Type
Device
Intervention Name(s)
ExAblate Pallidotomy
Other Intervention Name(s)
MRgFUS, Pallidotomy
Intervention Description
ExAblate Pallidotomy for Parkinson's Disease
Intervention Type
Device
Intervention Name(s)
Sham ExAblate Pallidotomy
Intervention Description
ExAblate MRgFUS Sham Procedure
Primary Outcome Measure Information:
Title
Responder Analysis
Description
Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
Time Frame
Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
Secondary Outcome Measure Information:
Title
Severity of Device and Procedure related complications
Description
To evaluate of the incidence and severity of device- and procedure-related
Time Frame
At the time of ExAblate Pallidotomy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 through 12 Months.
Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
Subject is able to communicate sensations during the ExAblate procedure.
Subjects on stable antidepressant medications for at least 3 months
Exclusion Criteria:
Hoehn and Yahr stage in the ON medication state of 3 or greater.
Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
Presence of significant cognitive impairment using MMSE ≤ 24.
Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
Subjects with unstable cardiac status
Severe hypertension (diastolic BP > 100 on 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 (e.g., Avastin) within one month of focused ultrasound procedure.
Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
Patient with kidney disease or on dialysis.
Subjects with standard contraindications for MR imaging
Significant claustrophobia that cannot be managed with mild medication.
Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
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.
Are participating or have participated in another clinical trial in the last 30 days.
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Palm Beach Neuroscience Institute/Sperling Medical Group
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York University Health Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pennsylvania Hospital Department of Neurosurgery
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Rambam Health Care
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Fondazione IRCCS Neurological Institute Carlo Besta
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Verona, Univerista di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
CINAC-Hospital HM Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Clinica Universidad De Navarra
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
Chang Bing Show Chwan Memorial Hospital
City
Changhua
Country
Taiwan
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
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ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
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