Clinical trial NCT05922644: Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coma
Stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
name: Shenzhen Qianhai Shekou Free Trade Zone Hospital
First posted: 2023-06-28
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Change in consciousness 12 months after surgery assessed by CRS-R
timeFrame: 12 months
Secondary outcomes:
measure: Consciousness recovery 12 months after surgery assessed by GOS-E
timeFrame: 12 months
Other outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: 12 months
measure: National Institute of Health stroke scale (NIHSS)
timeFrame: 12 months
measure: Full Outline of UnResponsiveness (FOUR) Score
timeFrame: 12 months
measure: Disability rating scale (DRS)
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: