Cervical spinal cord stimulation for patients with disorders of consciousness after brain 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05922644 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with secondary brain injuries, unstable vital signs, or contraindications for spinal cord surgery may not benefit from this study.
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 performed: While there is limited research on cervical spinal cord stimulation for DOC, other neuromodulation techniques have shown promise in similar contexts.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yong Cao, MD
- Email: caoyong@bjtth.org
- Phone: +8613601362306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.