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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03319485
• Other study ID #: PD006
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Device:
• ExAblate Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
• Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
Israel	Rambam Health Care	Haifa
Italy	Fondazione IRCCS Neurological Institute Carlo Besta	Milan
Italy	Azienda Ospedaliera Universitaria di Verona, Univerista di Verona	Verona
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Spain	CINAC-Hospital HM Puerta del Sur	Móstoles	Madrid
Spain	Clinica Universidad De Navarra	Pamplona	Navarre
Taiwan	Chang Bing Show Chwan Memorial Hospital	Changhua
United Kingdom	St. Mary's Hospital	London
United States	University of Maryland Medical System	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Palm Beach Neuroscience Institute/Sperling Medical Group	Boynton Beach	Florida
United States	University of Virginia Health System	Charlottesville	Virginia
United States	The Ohio State Wexner Medical Center	Columbus	Ohio
United States	New York University Health Langone	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Pennsylvania Hospital Department of Neurosurgery	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Italy,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of Device and Procedure related complications	To evaluate of the incidence and severity of device- and procedure-related	At the time of ExAblate Pallidotomy procedure