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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02252380
• Other study ID #: MD003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Dystonia
• Essential Tremor
• Holmes Tremor
• Huntington Disease
• Huntington's Disease
• Movement Disorders
• Orofacial Dyskinesias
• Parkinson Disease
• Parkinson's Disease
• Tardive Dyskinesia
• Tremor
• Wilson's Disease

Intervention

Device:
• Transcranial ExAblate System
MR Guided Focused Ultrasound

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Device and Procedure Related Complications	Safety will be evaluated individually for each subject who is treated	At the time of ExAblate procedure