Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuashan Hospital
About this trial
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;
Patients with contraindications for surgery, such as acute infections or coagulation disorders;
Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;
Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;
Trial design
Treatments tested in this trial
- SCS Stimulation
- Sham Stimulation
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Huashan Hospital
Lead sponsor
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Source ClinicalTrials.gov