Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage: a Multicenter, Prospective, Randomized, Outcome-blind Interventional Study

Conditions
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Coma, Stroke

Intervention / Treatment
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* Device: SCS
* Other: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Contraindications for spinal cord surgery Severe sympathetic overactivity syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal cord electrical stimulation group<br>According to the EDC system, patients are randomly assigned to receive 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment. | Device: SCS<br>* 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.<br>|
| Sham Comparator: Conventional treatment group<br>According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment. | Other: Conventional<br>* Routine brain resuscitation and rehabilitation awakening treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months |