Essential Tremor
Conditions
Interventions
Experimental group:The intervention group was provided with fully functional trial devices for self-use in a home setting over a 14-day period. Participants were required to accumulate at least 2 hour
Control group:The sham treatment devices were distributed, and control group participants were informed that experiencing no abnormal sensations after wearing the device was normal. The sham treatment
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. According to the "Diagnostic and Treatment Guidelines for Primary Tremor in China (2020)", diagnosed with primary tremor; 3. Clinical grade of primary tremor > 2; 4. Within the 30 days prior to enrollment, no tremor-related drug treatment was received, or the tremor-related drug treatment was ongoing with a stable dose for >= 30 days; 5. Within the 90 days prior to enrollment, no antidepressant drug treatment was received, or the antidepressant drug treatment was ongoing with a stable dose for >= 90 days; 6. Willing to cooperate with the trial, including: a) Maintaining a stable dose of tremor-related drug treatment and/or antidepressant drug treatment during the trial (if applicable) b) Avoiding alcohol and caffeine intake 4 hours before each visit assessment c) Being able to cooperate with the completion of standardized video shooting d) Being able to cooperate with the completion of the scale assessment as stipulated in the protocol 7. Understand the purpose of this trial and voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Implantation of electronic medical devices in the body, such as pacemakers, defibrillators, deep brain stimulation electrodes, etc. 2. Previous surgical treatment history related to tremor symptoms, such as deep brain stimulation surgery, stereotactic thalamic lesion surgery, magnetic resonance-guided focused ultrasound thalamic incision surgery, etc. 3. Received A-type botulinum toxin injection treatment for upper limb tremors within 6 months before enrollment. 4. Have a known or suspected history of epilepsy or other diseases that have caused epileptic seizures. 5. Have skin lesions or anatomical abnormalities in the hand or forearm, such as open wounds, swelling, infection, inflammation, canceration, scar contracture, developmental abnormalities, fractures, etc., which affect the wearing and use of the devices. 6. Have peripheral nerve or muscle lesions that affect upper limb movement. 7. Have other neurodegenerative diseases, such as multiple system atrophy, progressive supranuclear palsy, Lewy body dementia, Alzheimer's disease, etc. 8. Have secondary tremors. 9. Have a history of drug abuse or alcoholism. 10. Have severe mental disorders and are unable to cooperate with the trial. 11. Pregnant women, lactating women, or those with fertility plans during the trial period. 12. Participated in other interventional clinical trials within 1 month before enrollment. 13. The investigator considers the participant unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FTM Tremor Assessment Scale Score from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FTM Tremor Assessment Scale Subitem Scores;Change in BF-ADL Scale Score from Baseline;Change in QUEST questionnaire scores relative to baseline;Overall improvement in impression scores(CGI-I) ;Patient Global Impression of Improvement Score (PGI-I);Improvement rate of video analysis metrics;Reliability of Video Analysis Metrics;Validity of Video Analysis Metrics;Sensitivity of Video Analysis Metrics;User compliance; | — |
Countries
China
Contacts
Public ContactMianwang He
Chinese PLA General Hospital
Outcome results
None listed