Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
NCT Number: NCT05922644
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
Routine brain resuscitation and rehabilitation awakening treatment.
Time frame: 12 months
The primary efficacy indicator is "change in consciousness recovery 12 months after cervical spinal cord electrical stimulation (assessed by the Coma Recovery Scale - Revised (CRS-R), ranges from 0 to 25, with higher scores mean a better outcome)".
Time frame: 12 months
The secondary efficacy indicator is "consciousness recovery 12 months after surgery (assessed by the Glasgow Outcome Scale - Extended (GOS-E) to evaluate the patient's consciousness status, ranges from 0 to 8, with higher scores mean a better outcome)".
Time frame: 12 months
Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.
Time frame: 12 months
Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.
Time frame: 12 months
Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.
Time frame: 12 months
Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.
Contact information is provided by the study sponsor or research team.
Qiheng He, MD
CONTACT
Yong Cao, MD
CONTACT
Beijing Tiantan Hospital
Other
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
Acronym: SCS-ICH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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