A Study to Evaluate the Safety and Efficacy of Staged Bilateral Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for the Treatment of Essential Tremor

NCT06676501 | Enrolling By Invitation DMC

• 1 other identifier: 301ET-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective, single-arm, open-label study is to asses the safety and efficacy of the staged bilateral thalamotomy using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.

Conditions

Essential Tremor; Essential Tremor, Movement Disorders

Keywords

MRgFUS; focused ultrasound; Thalamotomy

Outcome Measures

Primary Outcomes (1)

• Number of Device and Procedure Related Adverse Events

  The cumulative sum of adverse events was followed through Year 2 of the study

  2 Years post treatment

Secondary Outcomes (1)

• Tremor Motor Score - Clinical Rating Scale for Tremor (CRST)

  Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment

Study Arms (1)

ExAblate Treatment

EXPERIMENTAL

Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS

Procedure: ExAblate

Interventions

ExAblate PROCEDURE

Transcranial focused ultrasound thalamotomy

ExAblate Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 22 years or older
• Subject is able and willing to give consent and able to attend all study visits
• Subject is diagnosed with Essential Tremor as confirmed by a movement disorder specialist
• Subject's tremor is refractory to adequate trials of at least two medications, one of which being a first line therapy of either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
• Subject is diagnosed with medication-refractory Essential Tremor
• A subject who underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
• Subject has a baseline CRST Part A score of 2 or above for postural or intention tremor severity in the upper extremity for the contralateral tremor side while on stable medication
• Subject is able to communicate sensations during the Exablate thalamotomy procedure.
• Subject has a baseline CRST Part C score of 2 or above in any one of the items (speaking, eating, drinking, hygiene, dressing, writing, working, and social activities).

You may not qualify if:

• Subject experienced any non-transient neurological event or worsening following the Exablate index procedure
• Subject has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia
• Subject has score \<22 on the Montreal Cognitive Assessment (MoCA)
• Subject has any non-transient hemiparesis as determined by physical examination
• Subject with clinically significant abnormal speech function as determined by a speech pathologist
• Subject of childbearing potential is pregnant or breastfeeding
• Subject with unstable cardiac status including:
• Unstable angina pectoris on medication
• documented myocardial infarction within six months of enrollment
• Unstable or worsening congestive heart failure
• History of a hemodynamically unstable cardiac arrhythmia
• Cardiac pacemaker
• Severe hypertension (diastolic BP \> 100 on medication)
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
• Subject has history of abnormal systemic or intracranial bleeding, hemorrhage, or coagulopathy

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Essential Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Longsheng Pan Professor, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: September 26, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)