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

NCT01698450 | Completed Phase 1 DMC

• 1 other identifier: EK: 2012-0027
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound neurosurgery.

Conditions

Essential Tremor; Dystonia; Parkinson's Disease

Keywords

FUS; focused ultrasound; functional brain disorder; neuropathic pain; movement disorders; malignant brain tumors

Outcome Measures

Primary Outcomes (2)

• Lesion Size

  Size of lesion in the target area for each sonication as a function of applied energy/temperature.

  3 months

• Patient Safety

  Number of Patients with Adverse Events as a Measure of Safety and Tolerability.

  3 months

Secondary Outcomes (1)

• Clinical efficacy and QOL

  3 months

Study Arms (1)

Focused Ultrasound for Movement Disorders

OTHER

Device: Non-invasive intervention with focused ultrasound (ExAblate 4000)

Interventions

Non-invasive intervention with focused ultrasound (ExAblate 4000) DEVICE

Non-invasive brain intervention using MR-guided focused ultrasound

Also known as: ExAblate 4000

Focused Ultrasound for Movement Disorders

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 a MD, such as Essential Tremor (ET), Idiopathic Parkinson's diseases or primary Dystonia as confirmed from clinical history and examination by a movement disorder neurologist.
• A MD refractory to adequate medical treatment, or in whom the indication for Deep Brain Stimulation (DBS) would be given, but DBS cannot be performed because of medical comorbidities or medical reasons, or because the patient clearly confirms by written statement that he does not want to undergo DBS for personal reasons (PD: increasing motor fluctuations albeit optimal medical treatment \& unbearable side effects of medication; ET: failure of adequate tremor control with Propranolol and Primidone alone and in combination; Dystonia: dystonia or pain not controlled by oral medication). 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.
• Either the medial thalamic nuclei or the subthalamic or pallidal areas can be target by the ExAblate device. The target region must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from landmarks, using the "Stereotactic Atlas of the Human Thalamus and Basal Ganglia" by Anne Morel, 39 analogous to our first clinical FUS study on patients with chronic pain 33.
• Able to communicate sensations during the ExAblate MRgFUS treatment
• Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
• Significant disability due to MD despite medical treatment (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
• Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
• Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
• Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
• Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
• Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
• 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) including advanced kidney disease
• Severely impaired renal function (estimated glomerular filtration rate \< 45ml/min/ 1.73 m2) or receiving dialysis
• History of abnormal bleeding and/or coagulopathy

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

MR-Center, University Children's Hospital

Zurich, Canton of Zurich, Switzerland

Location

MeSH Terms

Conditions

Essential Tremor; Dystonia; Parkinson Disease; Neuralgia; Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain

Study Officials

• Ernst - Martin, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

• Ronald - Bauer, MD

  Neurosurgey, Kantonsspital St. Gallen, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: October 3, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

CH (1)