Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor

NCT07006740 | Not Yet Recruiting

• 2 other identifiers: RP2025-023-002BJGBYY-IIT-LCYJ-2025-023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Essential tremor (ET) is one of the most common movement disorders, significantly impacting patients' quality of life. Many patients do not respond well to medication or cannot tolerate side effects, leaving limited treatment options. Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is a noninvasive, targeted therapy that offers a promising alternative to surgical procedures such as deep brain stimulation. This study is a multicenter, non-randomized controlled observational study designed to evaluate the safety and effectiveness of unilateral MRgFUS thalamotomy targeting the ventral intermediate nucleus (VIM) in patients with medication-refractory essential tremor. Participants will be divided into two groups based on clinical evaluation and patient preference: the treatment group receiving MRgFUS and the control group receiving standard medical therapy. Both groups will undergo regular follow-up for one year. The primary outcome is improvement in tremor severity as measured by the Fahn-Tolosa-Marin Tremor Rating Scale and the Clinical Rating Scale for Tremor. Secondary outcomes include quality of life, cognitive and emotional status, and treatment-related adverse events. Eligible participants are adults aged 22 years or older who have a confirmed diagnosis of essential tremor and are significantly impaired despite medication. The goal is to assess whether MRgFUS provides sustained tremor relief and improves quality of life in comparison to standard care, while maintaining an acceptable safety profile.

Conditions

Essential Tremor

Keywords

Essential Tremor; MRgFUS; Focused Ultrasound; VIM Thalamotomy; Noninvasive Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in Tremor Severity Assessed by the Fahn-Tolosa-Marin Tremor Rating Scale (FTM)

  Tremor severity will be assessed using the Fahn-Tolosa-Marin Tremor Rating Scale (FTM), which evaluates tremor at rest, with posture, and during action. The scale ranges from 0 to 144, with higher scores indicating more severe tremor.

  Baseline and 12 months

Study Arms (2)

MRgFUS Group

Participants in this group will undergo unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy targeting the ventral intermediate nucleus (VIM) of the thalamus. The procedure is non-invasive and performed under MRI guidance. Subjects will be followed prospectively for 12 months to assess changes in tremor severity, quality of life, and safety outcomes.

Procedure: MR-guided Focused Ultrasound Thalamotomy

Medical Therapy Group

Participants in this group will receive standard medical therapy for essential tremor, which may include beta-blockers (such as propranolol), primidone, or other clinically indicated medications. Treatment plans will be determined by the attending physicians according to routine clinical practice. Participants will be followed for 12 months to assess changes in tremor severity, quality of life, and safety outcomes, consistent with the surgical treatment group.

Interventions

MR-guided Focused Ultrasound Thalamotomy PROCEDURE

This intervention involves a unilateral magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy targeting the ventral intermediate nucleus (VIM) of the thalamus. The procedure is non-invasive and uses MRI guidance to deliver focused ultrasound energy to ablate the target area. It is performed without surgical incisions or implanted devices. The intervention is intended for patients with medication-refractory essential tremor. Participants receiving this intervention will be followed for 12 months to assess efficacy and safety.

MRgFUS Group

Eligibility Criteria

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

Study Population

Adult patients (aged 22 years and older) diagnosed with medication-refractory essential tremor. Participants will be recruited from outpatient neurology clinics at multiple centers in China. All participants must be capable of providing informed consent and willing to complete a 12-month follow-up.

You may qualify if:

• Age ≥ 22 years
• Diagnosis of essential tremor confirmed by clinical criteria
• Medication-refractory tremor with significant functional impairment
• Ability to provide informed consent
• Willingness to undergo follow-up assessments for 12 months

You may not qualify if:

• History of other neurological disorders (e.g., Parkinson's disease)
• Presence of unstable medical conditions (e.g., uncontrolled hypertension)
• Contraindications to MRI (e.g., implanted metal devices)
• Severe cognitive impairment or psychiatric illness
• Pregnancy or breastfeeding

Sponsors & Collaborators

• meishanshan: lead
• Beijing GoBroad Hospital: collaborator

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jingyue Liu, MD, PhD

CONTACT

400-696-2000; cats998@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Neurologist, Department of Neurology, Beijing Gaobo Hospital, M.D., Ph.D.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 5, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 10, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication and will be available for up to 3 years.
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access to the de-identified individual participant data and related documents (such as the study protocol and statistical analysis plan). Data will be shared upon reasonable request under a data use agreement. Requests can be submitted by contacting the study sponsor at \[your email address here\].

Locations

CN (1)