essential tremor
Conditions
Interventions
interference group:temporal interference stimulation
control group:transcranial electric stimulation
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and <=80 years, regardless of gender; 2. Diagnosis of essential tremor or essential tremor plus according to the Consensus Statement on the classification of tremors from the task force on tremor of the International Parkinson and Movement Disorder Society; 3. Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) score =2 for postural or intention tremor in the distal part of either upper limb; 4. Voluntary participation in the study, with a dated informed consent form signed, commitment to comply with the study procedures, and cooperation throughout the entire research process;
Exclusion criteria
Exclusion criteria: 1. History of severe neurological disorders, such as severe cerebral atrophy, brain injury, neurosurgery, or cerebrovascular diseases. 2. Dementia or cognitive impairment (Mini-Mental State Examination score 17 or Hamilton Anxiety Rating Scale score > 21). 4. Major medical conditions that may interfere with study procedures or confound the evaluation of study endpoints. 5. Pregnancy or lactation. 6. Persistent head tremor while lying down. 7. Severe cranial deformity. 8. Claustrophobia. 9. Excessive body weight precluding entry into the MRI scanner. 10. Implanted materials such as intracranial aneurysm clips, cardiac implantable electronic devices, cochlear implants, or metal-containing dental, orthopedic, or gynecological implants. 11. Previous treatment with deep brain stimulation or transcranial electrical stimulation. 12. Previous treatment with focused ultrasound therapy. 13. Botulinum toxin injection within the past year. 14. Planned treatment during the follow-up period with deep brain stimulation, transcranial electrical stimulation, botulinum toxin, or focused ultrasound therapy. 15. Current participation in other clinical trials. 16. Other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FTM-TRS A; | — |
Secondary
| Measure | Time frame |
|---|---|
| FTM-TRS-A+B+C;FTM-TRS-B+C;FTM-TRS-C;CCAS-Scale;fMRI-BOLD;FTM-TRS-A+B;FTM-TRS-B;EEG Amplitude;GRC;Clinical Global Impression, CGI;Tremor Acceleration Analysis; | — |
Countries
China
Contacts
Public ContactWu Yiwen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed