N/A
N=61
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT02289560 ↗Enrolled (actual)
61
Serious AEs
3.3%
Results posted
Jul 2024
Primary outcome: Primary: Number of Device and Procedure Related Adverse Events. — 121 Number of adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial ExAblate (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- InSightec
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Device and Procedure Related Adverse Events. |
121 | — |
| SECONDARY Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed |
19.0; 6.3; 7.0; 7.4; 7.3; 7.3 | — |
| SECONDARY Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline |
2.8; 0.7; 0.8; 0.7; 0.5; 0.6 | — |
| SECONDARY Clinical Rating Scale for Tremor Part C - Activities of Daily Living. |
16.7; 3.5; 3.8; 5.8; 6.1; 8.3 | — |
| SECONDARY Quality of Life in Essential Tremor Total (QUEST) |
42.9; 17.8; 18.6; 19.60; 21.0; 24.0 | — |
Summary
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients 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 (NCT02289560). 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.