NCT05922644Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- First submitted
- 25 May 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT05922644
What you commit to
- Study type: Interventional
- Planned participants: 344
- From 1 Jul 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous epileptic seizures
- Contraindications for spinal cord surgery
Other illness
- Critical condition, unstable intracranial condition, risk of rebleeding
- Severe sympathetic overactivity syndrome.
Other
- Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
- Unstable vital signs requiring mechanical ventilation
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.