NCT05922644 Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
| NCT ID | NCT05922644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Coma |
| Study Type | INTERVENTIONAL |
| Enrollment | 344 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 344 participants in total. It began in 2023-07-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05922644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Coma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05922644 currently recruiting?
Yes, NCT05922644 is actively recruiting participants. Contact the research team at caoyong@bjtth.org for enrollment information.
Where is the NCT05922644 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05922644 clinical trial?
NCT05922644 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 344 participants.