ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

Sponsor

InSightec (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02252380

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.

Condition or Disease	Intervention/Treatment	Phase
Movement Disorders Essential Tremor Holmes Tremor Parkinson's Disease Wilson's Disease Huntington's Disease Dystonia Tardive Dyskinesia Orofacial Dyskinesias	Device: Transcranial ExAblate System	N/A

Detailed Description

The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:

FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcranial ExAblate System Transcranial ExAblate System (MRgFUS)	Device: Transcranial ExAblate System MR Guided Focused Ultrasound Other Names: MRgFUS Focused Ultrasound FUS

Arm

Intervention/Treatment

Experimental: Transcranial ExAblate System

Transcranial ExAblate System (MRgFUS)

Device: Transcranial ExAblate System

MR Guided Focused Ultrasound

Other Names:

MRgFUS

Focused Ultrasound

FUS

Outcome Measures

Primary Outcome Measures

Severity of Device and Procedure Related Complications [At the time of ExAblate procedure]
Safety will be evaluated individually for each subject who is treated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women, between 18 and 85 years, inclusive.
Subjects who are able and willing to give consent and able to attend all study visits.
A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:

o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics

Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
Able to communicate sensations during the ExAblate Neuro treatment
Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

Patients with unstable cardiac status including:
Unstable angina pectoris on medication
Patients with documented myocardial infarction within six months of protocol entry
Congestive heart failure requiring medication (other than diuretic)
Patients on anti-arrhythmic drugs
Severe hypertension (diastolic BP > 100 on medication)
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
Cerebrovascular disease (multiple CVA or CVA within 6 months)
Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
Untreated, uncontrolled sleep apnea
Active or suspected acute or chronic uncontrolled infection
History of intracranial hemorrhage
Individuals 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
Patients unable to communicate with the investigator and staff.
Presence of any other neurodegenerative disease like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
Patients with a history of seizures within the past year
Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded.
Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
Patients with brain tumors
Any illness that in the investigator's opinion preclude participation in this study.
Pregnancy or lactation.
Patient is unable to provide his own consent for any reason.
Legal incapacity or limited legal capacity.
Patients who have DBS or a prior stereotactic ablation of the basal ganglia
History of immunocompromise, including patient who is HIV positive
Known life-threatening systemic disease