ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

NCT03319485 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PD006
• Study Type: interventional
• Target: 92
• Locations: 8 countries
• Sites: 20

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.

Conditions

Parkinson Disease

Keywords

ExAblate; MRgFUS; Pallidotomy

Outcome Measures

Primary Outcomes (1)

• 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).

  Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment

Secondary Outcomes (1)

• Severity of Device and Procedure related complications

  At the time of ExAblate Pallidotomy procedure

Study Arms (2)

ExAblate Pallidotomy

EXPERIMENTAL

ExAblate treatment for Advanced Idiopathic Parkinson's Disease

Device: ExAblate Pallidotomy

Sham ExAblate Pallidotomy

SHAM COMPARATOR

Sham (fake) treatment

Device: Sham ExAblate Pallidotomy

Interventions

ExAblate Pallidotomy DEVICE

ExAblate Pallidotomy for Parkinson's Disease

Also known as: MRgFUS, Pallidotomy

ExAblate Pallidotomy

Sham ExAblate Pallidotomy DEVICE

ExAblate MRgFUS Sham Procedure

Sham ExAblate Pallidotomy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• InSightec: lead

Study Sites (20)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Palm Beach Neuroscience Institute/Sperling Medical Group

Boynton Beach, Florida, 33472, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University Health Langone

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Pennsylvania Hospital Department of Neurosurgery

Philadelphia, Pennsylvania, 19106, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Rambam Health Care

Haifa, 3109601, Israel

Location

Fondazione IRCCS Neurological Institute Carlo Besta

Milan, 20133, Italy

Location

Azienda Ospedaliera Universitaria di Verona, Univerista di Verona

Verona, 37134, Italy

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

CINAC-Hospital HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Clinica Universidad De Navarra

Pamplona, Navarre, 31008, Spain

Location

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Publications (1)

• Krishna V, Fishman PS, Eisenberg HM, Kaplitt M, Baltuch G, Chang JW, Chang WC, Martinez Fernandez R, Del Alamo M, Halpern CH, Ghanouni P, Eleopra R, Cosgrove R, Guridi J, Gwinn R, Khemani P, Lozano AM, McDannold N, Fasano A, Constantinescu M, Schlesinger I, Dalvi A, Elias WJ. Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Disease. N Engl J Med. 2023 Feb 23;388(8):683-693. doi: 10.1056/NEJMoa2202721.

  PMID: 36812432 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pallidotomy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: February 9, 2018
• Primary Completion: July 25, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

IL (1); US (11); GB (1); KR (1); TW (1); CA (1); IT (2); ES (2)