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

Capital Medical University

Status: Enrolling

Conditions: Coma; Stroke

Treatments: Other: Conventional; Device: SCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05922644

2022GKZS0005

Details and patient eligibility

About

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.

Enrollment: 344 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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344 participants in 2 patient groups

Spinal cord electrical stimulation group

Experimental group

Description:

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.

Treatment:

Device: SCS

Conventional treatment group

Sham Comparator group

Description:

According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.

Treatment:

Other: Conventional