A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease

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

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 30 - 100 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus: Dyskinesia

Study Purpose:

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.

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More Details

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.

Phase: N/A Lead Sponsor: InSightec
Trial ID: 005101 Sponsor Type: Industry
Primary Country: Canada Additional Collaborators or Sponsors:
Estimated Enrollment: 116 Study Start Date: February 2018
Estimated Study Completion Date: December 2020 Source: ClinicalTrials.gov
Study Website:

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