NCT01772693

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

A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	ExAblate Transcranial MRgFUS	ExAblate Transcranial MR Guided Focused Ultrasound
DEVICE	Sham ExAblate Transcranial MRgFUS	Sham ExAblate Transcranial MR Guided Focused Ultrasound

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-04-26
• Completion: 2019-03-01
• First posted: 2013-01-21
• Last updated: 2020-10-09
• Results posted: 2020-10-09

Locations

2 sites across 1 country: United States