ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

NCT01772693 | Completed Results

• 1 other identifier: PD001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure. Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

Conditions

Parkinson's Disease

Keywords

ExAblate Transcranial MRgFUS

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment. Primary safety analyses are reported in the adverse events module.

  Month 3

Secondary Outcomes (3)

• Tremor Motor Score Percent Change From Baseline.

  Baseline, Month 3

• Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.

  Baseline, Month 3, Month 12

• Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities

  Baseline, Month 3, Month 12

Study Arms (2)

ExAblate Transcranial MRgFUS

EXPERIMENTAL

ExAblate Transcranial MR guided Focused Ultrasound

Device: ExAblate Transcranial MRgFUS

Sham ExAblate Transcranial MRgFUS

SHAM COMPARATOR

Sham treatment with ExAblate MR guided Focused Ultrasound

Device: Sham ExAblate Transcranial MRgFUS

Interventions

ExAblate Transcranial MRgFUS DEVICE

ExAblate Transcranial MR Guided Focused Ultrasound

Also known as: ExAblate, MRgFUS, Focused Ultrasound, Transcranial MRgFUS Thalamotomy

ExAblate Transcranial MRgFUS

Sham ExAblate Transcranial MRgFUS DEVICE

Sham ExAblate Transcranial MR Guided Focused Ultrasound

Sham ExAblate Transcranial MRgFUS

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 30 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 idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
• Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
• Subject exhibits a significant disability from their PD tremor despite medical treatment
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

You may not qualify if:

• Subjects with unstable cardiac status
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Bond AE, Shah BB, Huss DS, Dallapiazza RF, Warren A, Harrison MB, Sperling SA, Wang XQ, Gwinn R, Witt J, Ro S, Elias WJ. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Dec 1;74(12):1412-1418. doi: 10.1001/jamaneurol.2017.3098.

  PMID: 29084313 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

This is a feasibility trial with no pre-defined hypothesis testing. It is primarily a safety trial with a secondary objective of collecting efficacy outcomes for developing future pivotal trials.

Results Point of Contact

• Title: Nadir Alikacem, Ph.D., VP Clinical Research
• Organization: Insightec

nadira@insightec.com

214-630-2000

Study Officials

• Jeff Elias, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single factor. ExAblate test verses ExAblate placebo randomized 2:1.

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: January 21, 2013
• Study Start: September 1, 2012
• Primary Completion: April 26, 2016
• Study Completion: March 1, 2019
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-07

Locations

US (2)