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

InSightec

Status

Active, not recruiting

Conditions

Wilson's Disease

Tardive Dyskinesia

Orofacial Dyskinesias

Huntington's Disease

Essential Tremor

Dystonia

Parkinson's Disease

Movement Disorders

Holmes Tremor

Treatments

Device: Transcranial ExAblate System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02252380

MD003

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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