Condition or disease | Intervention/treatment | Phase |
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Disorder of Consciousness Minimally Conscious State Vegetative State | Procedure: spinal cord stimulation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Random controlled trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | People who involved with data analysis and outcomes assessment would be blind to the randomization procedure. |
Primary Purpose: | Treatment |
Official Title: | Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS) |
Estimated Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
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No Intervention: Conventional treatment | |
Experimental: Spinal cord stimulation and conventional treatment |
Procedure: spinal cord stimulation
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.
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Ages Eligible for Study: | 14 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xuehai Wu, Ph.D. | +8613764880571 | wuxuehai2013@163.com | |
Contact: Ying Mao, Ph.D. | +862152887200 | maoying@fudan.edu.cn |
China, Shanghai | |
Department of Neurosurgery, Huashan Hospital | Recruiting |
Shanghai, Shanghai, China, 200000 | |
Contact: Xuehai Wu, Ph.D. +8613764880571 wuxuehai2013@163.com |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 18, 2019 | ||||||||
First Posted Date ICMJE | July 8, 2019 | ||||||||
Last Update Posted Date | July 8, 2019 | ||||||||
Estimated Study Start Date ICMJE | July 1, 2019 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Spinal Cord Stimulation in Patients With Disorders of Consciousness | ||||||||
Official Title ICMJE | Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS) | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description |
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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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Random controlled trial Masking: Single (Outcomes Assessor)Masking Description: People who involved with data analysis and outcomes assessment would be blind to the randomization procedure. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Procedure: spinal cord stimulation
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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 14 Years to 65 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04010838 | ||||||||
Other Study ID Numbers ICMJE | KY2017-329 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Xuehai Wu, Huashan Hospital | ||||||||
Study Sponsor ICMJE | Huashan Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Huashan Hospital | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |