N/A
N=76
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT01827904 ↗Enrolled (actual)
76
Serious AEs
6.2%
Results posted
Mar 2024
Primary outcome: Primary: Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline — 46.9; -0.1 Percent Change from Baseline — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial ExAblate (Device); Sham Transcranial ExAblate (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- InSightec
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline |
46.9; -0.1 | <0.001 sig |
| PRIMARY Number of Device and Procedure Related Adverse Events |
184; 26; 75 | — |
| SECONDARY Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline |
46.9; -0.1; 53.1; 43.1; 50.7; 39.6 | — |
| SECONDARY Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) |
64.3; -4.4; 56.4; 62.5; 56.8; 65.5 | — |
| SECONDARY Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline |
63.8; 1.8; 74.6; 61.8; 72.1; 64.0 | — |
| SECONDARY Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline |
43.2; 5.0; 59.2; 41.1; 58.4; 47.1 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01827904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.