Essential Tremor (ET)
Conditions
Interventions
Control group:None
Sponsors
Beijing Gaobo Hospital
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males and females aged 22 years or older; 2. Able to sign an informed consent form and complete a one-year follow-up; 3. Patients diagnosed with essential tremor (ET) by a movement disorder specialist according to the 2000 diagnostic criteria of the International Tremor Foundation (ITF); 4. After a one-month medication stabilization period, subjects must maintain stable treatment for tremor medications for one month. The stability visit will be conducted one month after the consent date; 5. Subjects with significant disability due to essential tremor despite medical treatment (a CRST score >=2 in any of items 16–23 under the disability section of the CRST: [speech, feeding other than liquids, transferring fluids to the mouth, hygiene, dressing, writing, work, and social activities]); 6. Subjects who have been on a stable antidepressant regimen for at least 3 months may participate in this study (i.e., no changes in medication or dosage for 3 months).
Exclusion criteria
Exclusion criteria: 1. Presence of MRI contraindications, such as non-MRI-compatible implanted metal devices (including pacemakers) or metal implants in the surgical area that cannot enter the MRI machine; 2. Subjects with severe cardiovascular diseases, including: unstable angina, myocardial infarction within six months prior to enrollment, heart failure, arrhythmia, severe hypertension (diastolic blood pressure >100 while on medication), or supine hypertension; 3. Cerebrovascular diseases such as acute cerebral infarction, history of intracranial hemorrhage, prior multiple (three or more) cerebral infarctions, or giant cerebral aneurysms; 4. Patients with intracranial tumors; 5. Subjects with a history of epilepsy; 6. Abnormal higher cortical function, such as a Mini-Mental State Examination (MMSE) score <=20 indicating cognitive impairment, or presence of psychiatric disorders or history; 7. Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, drowsiness, papilledema); 8. Systemic diseases such as hematologic disorders, history of abnormal bleeding and/or coagulation dysfunction, immune system diseases, infectious diseases (e.g., hepatitis B, HIV carriers), liver failure, active infection, or suspected acute or chronic uncontrolled infections; 9. Alcohol dependence and potential for drug abuse; 10. Subjects who cannot maintain a supine position for extended periods (total duration may exceed 4 hours) during treatment; 11. Subjects who have participated in or are currently participating in another clinical trial within the past 30 days; 12. Patients with claustrophobia; 13. Subjects unable to communicate with the investigator and study staff; 14. Subjects unable to perform grasping movements with both hands or whose thumbs cannot press buttons (the intraoperative protective mechanism requires the subject to be able to press the emergency stop button themselves); 15. Pregnant or breastfeeding subjects; 16. Subjects who have undergone deep brain stimulation or previous stereotactic ablation of the basal ganglia; 17. Subjects with a calculated total cranial bone density ratio <=0.3 (+/-0.05) based on screening CT; 18. Subjects with other diseases or conditions that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FTM Tremor Rating Scale;The Clinical Rating Scale for Tremor; | — |
Secondary
| Measure | Time frame |
|---|---|
| ET-specific Quality of Life Questionnaire;MoCAandHAMDandHAMA;Patient Global Impression; | — |
Countries
China
Contacts
Public ContactMei Shanshan
Beijing Gaobo Hospital
Outcome results
None listed