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

Phase 1
18 Years
80 Years
Not Enrolling
Essential Tremor

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Trial Information

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

Inclusion Criteria:

1. Men and women, between 18 and 80 years, inclusive

2. Patients who are able and willing to give consent and able to attend all study visits

3. A diagnosis of ET as confirmed from clinical history and examination by a movement
disorder neurologist

4. 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.

5. 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.

6. Able to communicate sensations during the ExAblate MRgFUS treatment

7. 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.

8. Stable doses of all medications for 30 days prior to study entry and for the duration
of the study.

9. May have bilateral appendicular tremor

10. 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])

11. Inclusion and exclusion criteria have been agreed upon by two members of the medical

Exclusion Criteria:

1. 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

2. 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

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).

3. Severe hypertension (diastolic BP > 100 on medication)

4. Patients with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.

5. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease

6. Severely impaired renal function (estimated glomerular filtration rate <
45ml/min/1.73 m2) or receiving dialysis

7. History of abnormal bleeding and/or coagulopathy

8. 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

9. Active or suspected acute or chronic uncontrolled infection

10. History of intracranial hemorrhage

11. Cerebrovascular disease (multiple CVA or CVA within 6 months)

12. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (can be up to 4 hrs of total table time.)

13. Symptoms and signs of increased intracranial pressure (e.g. headache, nausea,
vomiting, lethargy, and papilledema)

14. Are participating or have participated in another clinical trial in the last 30 days

15. Patients unable to communicate with the investigator and staff.

16. Presence of any other neurodegenerative disease like parkinson-plus syndromes
suspected on neurological examination. These include: multisystem atrophy,
progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.

17. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease. This
includes excluding anyone with the presence of parkinsonian features including
bradykinesia rigidity, or postural instability. Subjects who exhibit only mild
resting tremor but no other symptoms or signs of PD may be included.

18. Presence of significant cognitive impairment as determined with a score less than or
equal to 24 on the Mini Mental Status Examination (MMSE)

19. History of immunocompromise, including patient who is HIV positive

20. Known life-threatening systemic disease

21. Patients with a history of seizures within the past year

22. Patients with current or a prior history of any psychiatric illness will be excluded.
Any presence or history of psychosis will be excluded. Patients with mood disorders
including depression will be excluded. For the purpose of this study, we consider a
significant mood disorder to include any patient who has: been under the care of a
psychiatrist for over 3 months taken antidepressant medications for greater than 6
months has participated in cognitive-behavioral therapy been hospitalized for the
treatment of a psychiatric illness received transcranial magnetic stimulation
received electroconvulsive therapy

23. Patients with risk factors for intraoperative or postoperative bleeding (platelet
count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a
documented coagulopathy

24. Patients with brain tumors

25. Any illness that in the investigator's opinion preclude participation in this study.

26. Pregnancy or lactation.

27. Legal incapacity or limited legal capacity.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Device or procedure related Adverse Events reported

Outcome Description:

Safety of the ExAblate transcranial treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 3-Months post-treatment time point. Alternative treatments resulting from post-surgical changes in neurological status will be reported.

Outcome Time Frame:

3 Months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

October 2012

Related Keywords:

  • Essential Tremor
  • Tremor
  • Essential Tremor



University of VirginiaCharlottesville, Virginia  22908