NCT05922644

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coma
• Stroke

Interventions

Type	Name	Description
DEVICE	SCS	21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
OTHER	Conventional	Routine brain resuscitation and rehabilitation awakening treatment.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-09-01
• Completion: 2030-09-01
• First posted: 2023-06-28
• Last updated: 2023-07-03

Locations

1 site across 1 country: China