Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
| Condition(s) | Disorder of Consciousness, Spinal Cord Stimulation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness. |
| Who can participate | Inclusion Criteria: * Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease. * Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction. * Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt. * Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying). * The vital signs and s |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Huashan Hospital |
| Locations | Fuzhou, Fujian, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China |
| Start date | 2025-01-10 |
| NCT ID | NCT06515132 |
| Official listing | https://clinicaltrials.gov/study/NCT06515132 |