Cervical spinal cord stimulation for patients with disorders of consciousness after brain hemorrhage
Official title: 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
Run by Beijing Tiantan Hospital · NCT05922644 · Data updated 2026-11-12
This study tests if a new treatment using spinal cord stimulation can help patients who are not fully awake after a brain bleed become more alert and aware.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 344 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2030 |
| Registry record updated | July 3, 2023 |
| Trial ID | NCT05922644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 who have been in a state of DOC for more than 28 days following a cerebral hemorrhage.
✕Probably not a fit
Patients with secondary brain injuries, unstable vital signs, or contraindications for spinal cord surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of cervical spinal cord stimulation (SCS) on patients who have experienced disorders of consciousness (DOC) following intracerebral hemorrhage. Patients are divided into two groups: one receiving SCS treatment for 21 days and the other receiving conventional treatment. The goal is to assess whether SCS can promote wakefulness and improve consciousness levels in these patients. The study aims to provide a new therapeutic approach for DOC, which currently lacks effective treatments.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance recovery and quality of life for patients with disorders of consciousness.
How similar studies have gone: While there is limited research on cervical spinal cord stimulation for DOC, other neuromodulation techniques have shown promise in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yong Cao, MD
- Email: caoyong@bjtth.org
- Phone: +8613601362306
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.