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出境医 / 临床实验 / Spinal Cord Stimulation in Patients With Disorders of Consciousness

Spinal Cord Stimulation in Patients With Disorders of Consciousness

Study Description
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.

Condition or disease Intervention/treatment Phase
Disorder of Consciousness Minimally Conscious State Vegetative State Procedure: spinal cord stimulation Not Applicable

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.

Outcome Measures
Primary Outcome Measures :
  1. the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: at baseline (T0), which means 1 month before stimulation. ]
    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. the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 2 weeks after the end of the treatment (T1) ]
    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. the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 3 months after the end of the treatment (T2) ]
    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.

  4. the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 6 months after the end of the treatment(T3) ]
    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.


Secondary Outcome Measures :
  1. EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: at baseline (T0), which means 1 month before stimulation. ]
    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. EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 2 weeks after the end of the treatment (T1) ]
    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. EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 3 months after the end of the treatment (T2) ]
    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

  4. EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 6 months after the end of the treatment (T3) ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ages 14 to 65 years old;
  2. DOC patients, including vegetative state and minimally consciousness state.
  3. With normal body temperature, stable vital signs, spontaneous breathing without an extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
  4. Written informed consent from patient families

Exclusion Criteria:

  1. History of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
  2. With contraindications of spinal cord operations.
  3. Body temperature is abnormal, vital signs are not stable, still need a ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xuehai Wu, Ph.D. +8613764880571 wuxuehai2013@163.com
Contact: Ying Mao, Ph.D. +862152887200 maoying@fudan.edu.cn

Locations
Layout table for location information
China, Shanghai
Department of Neurosurgery, Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Xuehai Wu, Ph.D.    +8613764880571    wuxuehai2013@163.com   
Sponsors and Collaborators
Huashan Hospital
Tracking Information
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
 (submitted: July 4, 2019)
  • the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: at baseline (T0), which means 1 month before stimulation. ]
    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.
  • the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 2 weeks after the end of the treatment (T1) ]
    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.
  • the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 3 months after the end of the treatment (T2) ]
    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.
  • the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 6 months after the end of the treatment(T3) ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: at baseline (T0), which means 1 month before stimulation. ]
    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
  • EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 2 weeks after the end of the treatment (T1) ]
    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
  • EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 3 months after the end of the treatment (T2) ]
    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
  • EEG recording in resting state with Phase Coherence analysis(PC index) [ Time Frame: 6 months after the end of the treatment (T3) ]
    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
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.

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
Condition  ICMJE
  • Disorder of Consciousness
  • Minimally Conscious State
  • Vegetative State
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.
Study Arms  ICMJE
  • No Intervention: Conventional treatment
  • Experimental: Spinal cord stimulation and conventional treatment
    Intervention: Procedure: spinal cord stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
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:

  1. Patients ages 14 to 65 years old;
  2. DOC patients, including vegetative state and minimally consciousness state.
  3. With normal body temperature, stable vital signs, spontaneous breathing without an extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
  4. Written informed consent from patient families

Exclusion Criteria:

  1. History of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
  2. With contraindications of spinal cord operations.
  3. Body temperature is abnormal, vital signs are not stable, still need a ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xuehai Wu, Ph.D. +8613764880571 wuxuehai2013@163.com
Contact: Ying Mao, Ph.D. +862152887200 maoying@fudan.edu.cn
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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

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