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A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03319485
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 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 : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Device: Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure



Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) Score [ Time Frame: Change in UDysRS score from before treatment to 3 months following treatment ]
    To compare the change in total UDysRS score from Baseline to Month 3


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



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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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.
  6. Motor complications of PD on optimum medical treatment .
  7. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
  8. Subject is able to communicate sensations during the ExAblate procedure.
  9. 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.

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
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlene Aldrich    410-328-5332    CAldrich@som.umaryland.edu   
Principal Investigator: Howard Eisenberg, MD         
Sub-Investigator: Paul Fishman, MD         
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Mary O'Hehir    212-746-7373    mao2037@med.cornell.edu   
Contact: Alyson Hignight    212-746-1788    alh2031@med.cornell.edu   
Principal Investigator: Michael G. Kaplitt, MD, PhD         
United States, Ohio
The Ohio State Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Erin Woobburn    614-366-7822    Erin.Woodburn@osumc.edu   
Principal Investigator: Vibhor Krishna, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Matthew Patterson, MS    434-243-7336    MWP5F@hscmail.mcc.virginia.edu   
Principal Investigator: W Jeff Elias, MD         
Sponsors and Collaborators
InSightec

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03319485     History of Changes
Other Study ID Numbers: PD006
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by InSightec:
ExAblate
TcMRgFUS
Pallidotomy

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms