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Focused Ultrasound

Transcranial ExAblate for Essential Tremor

N/A
Waitlist Available
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post treatment.
Awards & highlights

Study Summary

This trial is testing a new treatment for essential tremor and demonstrating its safety.

Eligible Conditions
  • Essential Tremor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Device and Procedure Related Adverse Events
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline
Secondary outcome measures
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment)
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial ExAblateExperimental Treatment1 Intervention
Transcranial ExAblate
Group II: Sham Transcranial ExAblatePlacebo Group1 Intervention
Sham Treatment with Transcranial ExAblate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial ExAblate
2013
N/A
~80

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor
88 Previous Clinical Trials
3,628 Total Patients Enrolled
12 Trials studying Essential Tremor
992 Patients Enrolled for Essential Tremor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor
Elias, W. Jeffrey, Nir Lipsman, William G. Ondo, Pejman Ghanouni, Young G. Kim, Wonhee Lee, Michael Schwartz, et al.. 2016. “A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1600159.
NeurologyJournal
Three-year Follow-up of Prospective Trial of Focused Ultrasound Thalamotomy for Essential Tremor
Halpern, Casey H., Veronica Santini, Nir Lipsman, Andres M. Lozano, Michael L. Schwartz, Binit B. Shah, W. Jeff Elias, et al.. 2019. “Three-year Follow-up of Prospective Trial of Focused Ultrasound Thalamotomy for Essential Tremor”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000008561.
Journal of Neurology, Neurosurgery & PsychiatryJournal
Ipsilateral and Axial Tremor Response to Focused Ultrasound Thalamotomy for Essential Tremor: Clinical Outcomes and Probabilistic Mapping
Yamamoto, Kazuaki, Can Sarica, Gavin J B Elias, Alexandre Boutet, Jurgen Germann, Aaron Loh, Suresh E Joel, et al.. 2022. “Ipsilateral and Axial Tremor Response to Focused Ultrasound Thalamotomy for Essential Tremor: Clinical Outcomes and Probabilistic Mapping”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp-2021-328459.
Journal of NeurosurgeryJournal
Magnetic Resonance Imaging–guided Focused Ultrasound Thalamotomy for Essential Tremor: 5-year Follow-up Results
Cosgrove, G. Rees, Nir Lipsman, Andres M. Lozano, Jin Woo Chang, Casey Halpern, Pejman Ghanouni, Howard Eisenberg, et al.. 2022. “Magnetic Resonance Imaging–guided Focused Ultrasound Thalamotomy for Essential Tremor: 5-year Follow-up Results”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2022.6.jns212483.
~6 spots leftby Apr 2025
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