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

Not Applicable

Recruiting

• Conditions: Stroke; Coma
• Interventions: Device: SCS; Other: Conventional

• Registration Number: NCT05922644
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study Start: 2023-07-01
• Last Update Posted: 2023-07-03
• Primary Completion: 2026-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 344

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal cord electrical stimulation group	SCS	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.
Conventional treatment group	Conventional	According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.

Primary Outcome Measures

Name	Time	Method
Change in consciousness 12 months after surgery assessed by CRS-R	12 months	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 Outcome Measures

Name	Time	Method
Consciousness recovery 12 months after surgery assessed by GOS-E	12 months	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)".

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China