Trial Search Results

ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

InSightec

Intervention(s):

  • Device: Transcranial ExAblate
  • Device: Sham Transcranial ExAblate

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Men and women, age 22 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 Essential Tremor as confirmed from clinical history and
   examination by a neurologist or neurosurgeon specialized in movement disorder

   - Subject exhibits a significant disability from their ET despite medical treatment

   - Subjects should be on a stable dose of all ET 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

   - 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

Ages Eligible for Study

22 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Lillian Marcellus
Not Recruiting