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NCT01827904 · ClinicalTrials.gov registry record · NA
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
A NA study of Essential Tremor, sponsored by InSightec.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 8
- Study locations
NCT01827904: Completed NA study of Essential Tremor, sponsored by InSightec.
NCT01827904 is a NA study of Essential Tremor that has completed, run by InSightec. The registered enrollment target is 76 participants, below the 401-participant average among 41 other Essential Tremor trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827904, a NA study of Essential Tremor, has completed, sponsored by InSightec.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 8
- Study locations
Study 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).
Primary Outcome
The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (sh
Conditions Studied
Interventions
- DEVICE Transcranial ExAblate
- DEVICE Sham Transcranial ExAblate
Study Locations (8)
Other
- Tokyo Women's Medical University (TWMU) - Tokyo
- Yonsei University Medical Center - Seoul
California
- Stanford University Medical Center - Stanford
Maryland
- University of Maryland Medical System - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
Virginia
- University of Virginia - Charlottesville
Washington
- Swedish Medical Center - Seattle
Ontario
- Sunnybrook Health Sciences Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2013-05 |
| Est. Completion | 2021-02-24 |
| Phase | NA |
What the finished NCT01827904 record still lists
NCT01827904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 401-participant average among 41 other Essential Tremor trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 2 interventions - of which Transcranial ExAblate is the first listed.
NCT01827904 lists 8 locations in 7 states (Other, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT01827904 about?
NCT01827904 is a clinical study titled "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 Transcrania...
What is the current status of trial NCT01827904?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2013-05. Estimated completion is 2021-02-24.
What conditions does trial NCT01827904 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT01827904?
The interventions under investigation include: Transcranial ExAblate (DEVICE), Sham Transcranial ExAblate (DEVICE).
Who is sponsoring clinical trial NCT01827904?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01827904 being conducted?
This trial has 8 study locations across California, Maryland, Massachusetts, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01827904's enrollment target sits among peer trials
76 19th of 41 higher than 23 of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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