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Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
The spinal cord stimulation therapy is explorative at best at the moment. Attempts to improve the level of consciousness of patients in the different stages of DOC have shown some promise. Spinal cord stimulation(SCS) seem promising in some studies, suggesting that further research is needed. Current publications of DOC spinal cord stimulation therapy was not convincing because of the small number of patients and no randomized controlled trial. Therefore, there was much debate about the effectiveness of spinal cord stimulation therapy because of the limitation of our understanding of consciousness and the uncertainty of parameters of neuromodulation. The better understanding of brain function and large randomized trials are necessary. Future research should also focus on identifying specific neuro-biomarkers (i.e. neural network). So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
Scientific Issues Targeted:1) To figure out the effectiveness of spinal cord stimulation therapy using random controlled trial. 2) To explore individual parameters of SCS techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | No Intervention | ||
| Spinal cord stimulation and conventional treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal cord stimulation | Procedure | The spinal cord stimulation(SCS) is a type of implantable neuromodulation device (spinal cord stimulator) that is used to send electrical signals to select areas of the spinal cord (C2-C4 in this study) for the treatment of disorders of consciousness. |
| Measure | Description | Time Frame |
|---|---|---|
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors. | at baseline (T0), which means 1 month before stimulation. |
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors. | 2 weeks after the end of the treatment (T1) |
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors. | 3 months after the end of the treatment (T2) |
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| EEG recording in resting state with Phase Coherence analysis(PC index) | EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2 | at baseline (T0), which means 1 month before stimulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuehai Wu, Ph.D. | Contact | +8613764880571 | wuxuehai2013@163.com | |
| Ying Mao, Ph.D. | Contact | +862152887200 | maoying@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Random controlled trial
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People who involved with data analysis and outcomes assessment would be blind to the randomization procedure.
|
| 6 months after the end of the treatment(T3) |
| EEG recording in resting state with Phase Coherence analysis(PC index) | EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2 | 2 weeks after the end of the treatment (T1) |
| EEG recording in resting state with Phase Coherence analysis(PC index) | EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2 | 3 months after the end of the treatment (T2) |
| EEG recording in resting state with Phase Coherence analysis(PC index) | EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2 | 6 months after the end of the treatment (T3) |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014474 | Unconsciousness |