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| Name | Class |
|---|---|
| Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids | UNKNOWN |
| Shenzhen Nanshan District Shekou People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord electrical stimulation group | Experimental | According to the EDC system, patients are randomly assigned to receive 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment. |
|
| Conventional treatment group | Sham Comparator | According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCS | Device | 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in consciousness 12 months after surgery assessed by CRS-R | 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)". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Consciousness recovery 12 months after surgery assessed by GOS-E | 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)". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Coma Scale (GCS) | Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome. | 12 months |
| National Institute of Health stroke scale (NIHSS) | Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao, MD | Contact | +8613601362306 | caoyong@bjtth.org | |
| Qiheng He, MD | Contact | +8615699952258 | heqiheng96@mail.ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D003128 | Coma |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Conventional | Other | Routine brain resuscitation and rehabilitation awakening treatment. |
|
| 12 months |
| Full Outline of UnResponsiveness (FOUR) Score | Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome. | 12 months |
| Disability rating scale (DRS) | Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome. | 12 months |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |