Spasticity of the limbs caused by central nervous system injury
Conditions
Interventions
Trial Group:Stimulation on within 3 days after implantation
Control Group:Shame stimulation within 3 days after implantation. On the 30 days after implantation, stimulation on after completing the evaluation.
Sponsors
Beijing Tiantan Hospital , Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =6 months; 3. Severe spastic hypertonia (MAS score >=3); 4. Patients for whom medication and physical therapy are ineffective; 5. Presence of spastic hypertonia caused by central nervous system injury; 6. Basic cognitive understanding, able to follow simple instructions; 7. Overall health status sufficient to undergo implant surgery and subsequent device maintenance; 8. The subject and their family have a certain level of comprehension and expression ability, voluntarily agree to participate and sign the informed consent form, and can cooperate to complete the entire clinical trial.
Exclusion criteria
Exclusion criteria: 1. Accompanied by soft tissue fixed contractures. 2. Accompanied by joint deformities affecting mobility. 3. Accompanied by uncontrolled epilepsy, progressive encephalopathy, or spinal cord diseases. 4. Presence of active systemic or local infection at the surgical site. 5. Presence of active implanted devices in the body, such as pacemakers, defibrillators, drug infusion pumps, cochlear implants, deep brain stimulators, sacral nerve stimulators, etc., or passive implants that may affect the stimulator system. 6. Currently undergoing electroconvulsive therapy or transcranial magnetic therapy. 7. Current or planned experimental requirement for heat therapy. 8. History of suicide or a positive response to items 2–5 under "Suicidal Ideation" on the Columbia-Suicide Severity Rating Scale (C-SSRS). 9. Expected survival of less than one year. 10. Pregnant or breastfeeding women, or patients unable to use appropriate contraception during the study. 11. Cognitive impairment preventing participation in rehabilitation assessment and training. 12. Participation in another clinical trial or clinical research within the past three months. 13. Subjects judged by the investigator to have poor compliance or deemed unsuitable for participation in the study. 14. Subjects or their family members unable to fully understand the therapy, with unrealistic postoperative expectations, or unable to correctly complete the subject diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of treatment for spasticity disorders; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the change from baseline in Modified Ashworth Scale scores between treatment and control group;Difference in the change from baseline in VAS scores between treatment and control group;Change in VAS scores from baseline;Differences in changes from baseline in daily spasm frequency scale scores between treatment and control group;Change in daily spasm frequency scale score compared to baseline;Difference in the change from baseline in quality of life scale (ADL) scores between treatment and control group;Changes in Quality of Life Scale (ADL) Scores Compared to Baseline;The difference in changes from baseline in PHQ-9 scores between treatment and control group;Change in PHQ-9 score from baseline;Difference in the changes of Hmax/Mmax from baseline between treatment and control group;Changes in Hmax/Mmax relative to baseline;Effectiveness of treatment for spasticity disorders;Evaluation of device performance by investigators and subjects; | — |
Countries
China
Contacts
Public ContactJia Wenqing
Beijing Tiantan Hospital , Capital Medical University
Outcome results
None listed