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

This study is currently recruiting participants.
Verified February 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01772693
First received: November 28, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Parkinson's Disease
Device: ExAblate Transcranial MRgFUS
Device: Sham ExAblate Transcranial MRgFUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Severity of Device and Procedure related complications [ Time Frame: At the time of the ExAblate Transcranial thalamotomy procedure ] [ Designated as safety issue: Yes ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.


Secondary Outcome Measures:
  • UPDRS - Unified Parkinson's Disease Rating Scale [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    To evaluate the UPDRS score up to 3 months after ExAblate treatment.


Other Outcome Measures:
  • Severity of Device and Procedure related complications [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.

  • Incidence of Device and Procedure related complications [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.

  • Incidence of Device and Procedure related complications [ Time Frame: At the time of the ExAblate Transcranial thalamotomy procedure ] [ Designated as safety issue: Yes ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR guided Focused Ultrasound
Device: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR Guided Focused Ultrasound
Other Names:
  • ExAblate
  • MRgFUS
  • Focused Ultrasound
  • Transcranial MRgFUS Thalamotomy
Sham Comparator: Sham ExAblate Transcranial MRgFUS
Sham treatment with ExAblate MR guided Focused Ultrasound
Device: Sham ExAblate Transcranial MRgFUS
Sham ExAblate Transcranial MR Guided Focused Ultrasound

Detailed Description:

Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772693

Contacts
Contact: Johanna Loomba 434-243-1435 FUSbrain@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Johanna Loomba    434-243-1435    FUSbrain@virginia.edu   
Principal Investigator: Jeff Elias, M.D.         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Colleen Ottinger    206-320-3070    Focusedultrasound@swedish.org   
Contact: Mary Lessig    206-320-3070    Focusedultrasound@swedish.org   
Principal Investigator: Ryder Gwinn, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Jeff Elias, M.D. University of Virginia
  More Information

No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01772693     History of Changes
Other Study ID Numbers: PD001
Study First Received: November 28, 2012
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
ExAblate Transcranial MRgFUS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014