Parkinson's disease
Conditions
Interventions
Surgical group:Test treatment: Electrode implantation surgery
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The presence of limb spasticity accompanied by pain for a period of at least 6 months after brain injury; 2) Age between 18 and 70 years old; 3) The selected patients have a Fugl-Meyer score of at least 50 points (with MAS assessment of at least grade 3 or NRS of at least 3 points or NPQ of at least 10 points); 4) There is a significant improvement in limb spasticity or pain during the test period, and the subjects and their families have a strong willingness to undergo permanent implantation of the stimulator; 5) The subjects have a certain ability to understand and express themselves, and voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Persistent breathing difficulties exist; 2) Language or cognitive impairments are present; 3) Severe depression (Beck Depression Inventory score >=16); 4) Progressive brain disease is currently present; 5) There are surgical contraindications (e.g., history of adverse reactions to anesthetics, the surgeon deems the patient unsuitable for surgery, etc.); 6) Other stimulating devices such as pacemakers or other nerve stimulators are being used in the body, or other experimental devices or drugs are in use; 7) There is a requirement for heat therapy during the current period or the trial; 8) Obvious joint deformities exist; 9) Obvious tactile reduction exists; 10) Pregnant and lactating women, and patients who cannot take appropriate contraceptive measures during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer motor function score, FMA-UE;Modified Ashworth Spasticity Scale, MAS;Numerical Rating Scale, NRS;Neuropathic Pain Scale, NPQ;Neuroelectrophysiology, EMG/SSEP; | — |
Countries
China
Contacts
Public ContactSu Daoqing
Jinan Central Hospital (Capital Medical University Xuanwu Hospital Jinan Hospital)
Outcome results
None listed