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

Feasibility Trial Evaluating the Safety and Efficacy of ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for Unilateral Pallidotomy for the Treatment of L-Dopa Induced Dyskinesia (LID) of Parkinson's Disease.

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02347254

Enrollment

Registered

2015-01-27

Start date

2014-09-30

Completion date

2026-12-31

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DEVICETranscranial ExAblate

Transcranial ExAblate MRgFUS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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. * Inclusion and

Exclusion criteria

have been agreed upon by two members of the medical team.

Design outcomes

Primary

Measure	Time frame	Description
Number of Device and Procedure related adverse events	At the time of ExAblate trascranial procedure	To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.

Secondary

Measure	Time frame	Description
Severity of Device and Procedure related adverse events	At the time of ExAblate trascranial procedure	To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026