Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

InSightec

Status

Completed

Conditions

Essential Tremor

Treatments

Device: Transcranial ExAblate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02289560

ET002CA

Details and patient eligibility

About

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Full description

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Enrollment

61 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women, age 22 years and older
Subjects who are able and willing to give informed consent and able to attend all study visits
Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
Subject exhibits a significant disability from their ET despite medical treatment
Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion criteria

Subjects with unstable cardiac status
Severe hypertension
Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
Significant claustrophobia that cannot be managed with mild medication
Current medical condition resulting in abnormal bleeding and/or coagulopathy
Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
History of intracranial hemorrhage
History of multiple strokes, or a stroke within past 6 months
Subjects 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
Subjects unable to communicate with the investigator and staff
Subjects with a history of seizures within the past year
Subjects with brain tumors