ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease

NCT02347254 | Active Not Recruiting

• 2 other identifiers: PD004222434
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's disease (LID PD). Safety: To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease. Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months and 12-Months post-ExAblate treatment.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Device and Procedure related adverse events

  To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.

  At the time of ExAblate trascranial procedure

Secondary Outcomes (1)

• Severity of Device and Procedure related adverse events

  At the time of ExAblate trascranial procedure

Study Arms (1)

Transcranial ExAblate

EXPERIMENTAL

Transcranial ExAblate MRgFUS

Device: Transcranial ExAblate

Interventions

Transcranial ExAblate DEVICE

Transcranial ExAblate MRgFUS

Also known as: ExAblate, TcMRgFUS

Transcranial ExAblate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, between 18 and 80 years, inclusive.
• Patients who are able and willing to give consent and able to attend all study visits.
• Able to communicate sensations during the ExAblate MRgFUS treatment
• Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

You may not qualify if:

• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication
• Patients with documented myocardial infarction within six months of protocol entry
• Congestive heart failure requiring medication (other than diuretic)
• Patients on anti-arrhythmic drugs
• Severe hypertension (diastolic BP \> 100 on medication)
• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
• Severely impaired renal function (estimated glomerular filtration rate \< 30ml/min/1.73 m2) or receiving dialysis
• History of abnormal bleeding and/or coagulopathy
• Cerebrovascular disease (multiple CVA or CVA within 6 months)
• Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
• Active or suspected acute or chronic uncontrolled infection
• History of intracranial hemorrhage
• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 27, 2015
• Study Start: September 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

CA (1)