Clinical trial NCT03319485: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: ExAblate
MRgFUS
Pallidotomy
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Responder Analysis
timeFrame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment
Secondary outcomes:
measure: Severity of Device and Procedure related complications
timeFrame: At the time of ExAblate Pallidotomy procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Boynton Beach
country: United States
facility: Palm Beach Neuroscience Institute/Sperling Medical Group
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University Health Langone
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Columbus
country: United States
facility: The Ohio State Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital Department of Neurosurgery
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Haifa
country: Israel
facility: Rambam Health Care
city: Milan
country: Italy
facility: Fondazione IRCCS Neurological Institute Carlo Besta
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria di Verona, Univerista di Verona
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Móstoles
country: Spain
facility: CINAC-Hospital HM Puerta del Sur
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad De Navarra
state: Navarre
city: Changhua
country: Taiwan
facility: Chang Bing Show Chwan Memorial Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References: