We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced 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: NCT03319485
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: ExAblate Pallidotomy Device: Sham ExAblate Pallidotomy Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ExAblate Pallidotomy
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
 Device: ExAblate Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
Other Names:
  • MRgFUS
  • Pallidotomy
Sham Comparator: Sham ExAblate Pallidotomy
Sham (fake) treatment
 Device: Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Responder Analysis [ Time Frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment ]
    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 :
  1. Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Pallidotomy procedure ]
    To evaluate of the incidence and severity of device- and procedure-related


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, age 30 years and older.
  2. Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
  3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
  4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
  5. MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
  6. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
  7. Subject is able to communicate sensations during the ExAblate procedure.
  8. Subjects on stable antidepressant medications for at least 3 months

Exclusion Criteria:

  1. Hoehn and Yahr stage in the ON medication state of 3 or greater.
  2. 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.
  3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
  4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
  5. Presence of significant cognitive impairment using MMSE ≤ 24.
  6. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
  7. Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
  8. Subjects with unstable cardiac status
  9. Severe hypertension (diastolic BP > 100 on medication).
  10. Current medical condition resulting in abnormal bleeding and/or coagulopathy.
  11. 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.
  12. 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
  13. Patient with kidney disease or on dialysis.
  14. Subjects with standard contraindications for MR imaging
  15. Significant claustrophobia that cannot be managed with mild medication.
  16. Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
  17. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
  18. History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
  19. Subjects with a history of seizures within the past year.
  20. Subjects with brain tumors.
  21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  22. Are participating or have participated in another clinical trial in the last 30 days.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT03319485


Locations
Show Show 20 study locations
Sponsors and Collaborators
InSightec
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03319485    
Other Study ID Numbers: PD006
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by InSightec:
ExAblate
MRgFUS
Pallidotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations