ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2021-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor

NCT02037217

Essential Tremor

COMPLETED PHASE1

A Study to Evaluate the Safety and Efficacy of Staged Bilateral Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for the Treatment of Essential Tremor

NCT06676501

Essential Tremor Essential Tremor, Movement Disorders

ENROLLING_BY_INVITATION NA

Magnetic Resonance (MR) Guided Functional Ultrasound-Neurosurgery for Movement Disorders

NCT01698450

Essential Tremor Dystonia Parkinson's Disease

COMPLETED PHASE1

Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor

NCT03935581

Tremor, Essential Neurologic Manifestations Tremor

UNKNOWN NA

Cerebellar rTMS for Essential Tremor

NCT02704793

Essential Tremor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 randomized to either an ExAblate treatment or an ExAblate Sham or "fake" procedure. The chance of randomization to Sham is one out of four. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be unblinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an unblinded fashion, as long as they still qualify for ExAblate treatment. All subjects will be followed at 6 and 12 months and for up to 5 years as directed by their doctor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Tremor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transcranial ExAblate

Group Type EXPERIMENTAL

Transcranial ExAblate

Intervention Type DEVICE

Sham Transcranial ExAblate

Sham Treatment with Transcranial ExAblate

Group Type SHAM_COMPARATOR

Sham Transcranial ExAblate

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial ExAblate

Intervention Type DEVICE

Sham Transcranial ExAblate

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ExAblate TcMRgFUS Thalamotomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No