A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

InSightec

Status: Completed

Conditions: Neurologic Manifestations; Parkinson Disease

Treatments: Device: Exablate Bilateral Subthalamotomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03964272

PD010B

Details and patient eligibility

About

The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features

Full description

The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.

Enrollment: 6 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female age 30 years or older
2. Able and willing to give consent and able to attend all study visits
3. A confirmed diagnosis of Parkinsons Disease
4. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
5. Able to localize subthalamic nucleus on MRI for treatment
6. Able to communicate sensations during the ExAblate MRgFUS procedure

Exclusion criteria

1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
2. Presence of severe dyskinesia as noted by MDS-UPDRS scores
3. Presence of other central neurodegenerative disease
4. Parkinsonian symptoms are a side effect from neuroleptic medications
5. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
6. History of a bleeding disorder or receiving anticoagulant
7. Subjects with advanced kidney disease or on dialysis
8. Subjects with known intolerance or allergies to the MRI contrast agents.
9. Presence of unknown or MRI unsafe devices anywhere in the body.
10. History of multiple strokes, or a stroke within past 6 months
11. Subjects with a history of seizures within the past year
12. Subjects with malignant brain tumors
13. Women who are pregnant or nursing

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

ExAblate 4000 System

Experimental group

Description:

Exablate bilateral treatment for Parkinson's Disease Motor Features

Treatment:

Device: Exablate Bilateral Subthalamotomy