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

NCT ID: NCT07006740

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2027-06-10

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.

Detailed Description

Essential tremor (ET) is a progressive neurological disorder characterized primarily by action tremor affecting the upper limbs, head, or voice. Although ET is commonly treated with medications such as beta-blockers and anticonvulsants, a significant proportion of patients are either refractory to or intolerant of pharmacologic therapies. For these patients, surgical interventions such as deep brain stimulation (DBS) or thalamotomy may be considered. However, these procedures are invasive and associated with considerable risks and costs.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel, non-invasive technology that enables precise thermal ablation of brain targets, such as the ventral intermediate nucleus (VIM) of the thalamus, under real-time MRI guidance. MRgFUS offers advantages such as immediate effect, no need for implants, and lower complication rates.

This multicenter, non-randomized, controlled observational study aims to evaluate the real-world effectiveness and safety of unilateral MRgFUS VIM thalamotomy in patients with medication-refractory ET. Patients will be allocated into treatment or control groups based on clinical judgment and patient preference. The study will focus on assessing improvements in tremor severity, quality of life, and treatment safety over a 12-month follow-up period. The findings will provide evidence on the utility of MRgFUS as a non-invasive therapeutic option and help inform future clinical decision-making for ET management.

Conditions

Essential Tremor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MR-guided Focused Ultrasound Thalamotomy

Intervention Type: 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.

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.

No interventions assigned to this group

Interventions

MR-guided Focused Ultrasound Thalamotomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing GoBroad Hospital

OTHER

Sponsor Role: collaborator

meishanshan

OTHER

Sponsor Role: lead

Responsible Party

meishanshan

Associate Chief Neurologist, Department of Neurology, Beijing Gaobo Hospital, M.D., Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jingyue Liu, MD, PhD

Role: CONTACT

cats998@aliyun.com

400-696-2000

Facility Contacts

Ling Chen

Role: primary

22797303@qq.com

400-696-2000

Other Identifiers

BJGBYY-IIT-LCYJ-2025-023

Identifier Type: OTHER

Identifier Source: secondary_id

RP2025-023-002

Identifier Type: -

Identifier Source: org_study_id