About this trial
Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years old
Patients with postoperative consciousness disorders after cerebral hemorrhage for more than 28 days
CRS-R score meets the MCS diagnosis
Signed informed consent.
Disqualifiers
Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
History of previous epileptic seizures
Critical condition, unstable intracranial condition, risk of rebleeding
Unstable vital signs requiring mechanical ventilation
Trial design
Parallel
Treatments tested in this trial
SCS
Device21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
Conventional
Other interventionRoutine brain resuscitation and rehabilitation awakening treatment.
Treatment groups
Trial outcomes
Primary outcomes
Change in consciousness 12 months after surgery assessed by CRS-R
The primary efficacy indicator is "change in consciousness recovery 12 months after cervical spinal cord electrical stimulation (assessed by the Coma Recovery Scale - Revised (CRS-R), ranges from 0 to 25, with higher scores mean a better outcome)".
Secondary outcomes
Consciousness recovery 12 months after surgery assessed by GOS-E
The secondary efficacy indicator is "consciousness recovery 12 months after surgery (assessed by the Glasgow Outcome Scale - Extended (GOS-E) to evaluate the patient's consciousness status, ranges from 0 to 8, with higher scores mean a better outcome)".
Other outcomes
Glasgow Coma Scale (GCS)
Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.
National Institute of Health stroke scale (NIHSS)
Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.
Full Outline of UnResponsiveness (FOUR) Score
Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.
Disability rating scale (DRS)
Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.
Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Collaborator
Shenzhen Nanshan District Shekou People's Hospital
Collaborator