ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure. Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

Key facts

Study ID

NCT01772693

Run by

InSightec

People needed

27

Starts

2012-09-01

Expected to finish

2019-03-01

Last updated by the study team

2020-10-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
• Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
• Subject exhibits a significant disability from their PD tremor despite medical treatment
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

You may not qualify if…

• Subjects with unstable cardiac status
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
• Severe hypertension
• Subjects 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 including advanced kidney disease or severely impaired renal function
• Significant claustrophobia that cannot be managed with mild 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
• History of intracranial hemorrhage
• History of multiple strokes, or a stroke within past 6 months
• Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
• Are participating or have participated in another clinical trial in the last 30 days
• Subjects unable to communicate with the investigator and staff
• Subjects with a history of seizures within the past year
• Subjects with brain tumors
• Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
• Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia

Where it is running

• University of Virginia — Charlottesville, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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