Actively Recruiting
Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
Led by Beijing Tiantan Hospital · Updated on 2023-07-03
344
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
R
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Postoperative consciousness disorders after cerebral hemorrhage lasting more than 28 days
- Coma Recovery Scale-Revised (CRS-R) score consistent with minimally conscious state
- Signed informed consent
You will not qualify if you...
- Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor, or carbon monoxide poisoning
- History of previous epileptic seizures
- Critical or unstable intracranial condition with risk of rebleeding
- Unstable vital signs requiring mechanical ventilation
- Contraindications for spinal cord surgery
- Severe sympathetic overactivity syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Y
Yong Cao, MD
CONTACT
Q
Qiheng He, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here