ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor

NCT01932463 | Completed

• 1 other identifier: MD002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor

Conditions

Tremor; Essential Tremor

Keywords

Tremor; Essential Tremor; Medication-refractory Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Accuracy of Thalamotomy lesion

  Comparison of the stereotactic coordinates of the atlas to the lesion created in the brain.

  1 day

Study Arms (1)

ExAb;ate MRgFUS

EXPERIMENTAL

Device: ExAblate Transcranial System

Interventions

ExAblate Transcranial System DEVICE

MR Guided Focused Ultrasound

Also known as: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

ExAb;ate MRgFUS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, between 18 and 80 years, inclusive
• Patients who are able and willing to give consent and able to attend all study visits
• A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist
• Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
• Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.
• Able to communicate sensations during the ExAblate MRgFUS treatment
• Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale.
• Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
• May have bilateral appendicular tremor
• Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])

You may not qualify if:

• 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
• Alcohol or drug abuse within the past 6 months
• 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.
• Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
• Severely impaired renal function (estimated glomerular filtration rate \< 30ml/min/1.73 m2) or receiving dialysis
• History of 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 (e.g. Avastin) within one month of focused ultrasound procedure
• Active or suspected acute or chronic uncontrolled infection
• History of intracranial hemorrhage
• Cerebrovascular disease (multiple CVA or CVA within 6 months)

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print.

  PMID: 35995551 DERIVED

MeSH Terms

Conditions

Tremor; Essential Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 30, 2013
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

CA (1)