Essential TremorBJGB-ETNCT07006740
Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor
An observational study of Essential Tremor, run by meishanshan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- MR-guided Focused Ultrasound Thalamotomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to 10 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
Ling Chen, 400-696-2000, 22797303@qq.com
Shanshan Mei, MD, PhD
About this study
Official title: A Multicenter, Non-Randomized Controlled Observational Study on the Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor
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.
Read more
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.
Read the 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
- Being tested
- MR-guided Focused Ultrasound Thalamotomy
- Keywords
- Essential Tremor, MRgFUS, Focused Ultrasound, VIM Thalamotomy, Noninvasive Neuromodulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Focused Ultrasound ThalamotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- meishanshan
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing GoBroad Hospital
- Responsible party
- Sponsor-investigator, meishanshan, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006740
- Sponsor's protocol ID
- RP2025-023-002
- Other IDs
- BJGBYY-IIT-LCYJ-2025-023
- Acronym
- BJGB-ET
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article (after de-identification) will be shared upon reasonable request. Data will be available to qualified researchers with a data use agreement, starting 6 months after publication and for up to 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Randomized Controlled Observational Study on the Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor
- ClinicalTrials.gov ID
- NCT07006740
- Acronym / sponsor ID
- BJGB-ET / RP2025-023-002
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, MRgFUS, Focused Ultrasound, VIM Thalamotomy, Noninvasive Neuromodulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- meishanshanUniversity, hospital or other
- Collaborators
- Beijing GoBroad Hospital
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRgFUS Group | – | Procedure: MR-guided Focused Ultrasound ThalamotomyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-guided Focused Ultrasound ThalamotomyThis 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. | Procedure or surgery | MRgFUS Group |
Primary outcome
Change in Tremor Severity Assessed by the Fahn-Tolosa-Marin Tremor Rating Scale (FTM)
Time frame: Baseline and 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article (after de-identification) will be shared upon reasonable request. Data will be available to qualified researchers with a data use agreement, starting 6 months after publication and for up to 3 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by meishanshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyue Liu, MD, PhD (400-696-2000, cats998@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tremor Severity Assessed by the Fahn-Tolosa-Marin Tremor Rating Scale (FTM) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.