Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Cord Stimulation in Patients With Disorders of Consciousness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010838
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xuehai Wu, Huashan Hospital

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.

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

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010838


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
Layout table for additonal information
Responsible Party: Xuehai Wu, Professor, Huashan Hospital, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04010838    
Other Study ID Numbers: KY2017-329
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuehai Wu, Huashan Hospital:
disorders of consciousness
spinal cord stimulation
DoC
SCS
Additional relevant MeSH terms:
Layout table for MeSH terms
Consciousness Disorders
Persistent Vegetative State
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Unconsciousness