Spinal Cord Stimulation in Patients With Disorders of Consciousness

Sponsor

Huashan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04010838

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Random controlled trialRandom 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)

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 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.

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

the JFK Coma Recovery Scale-Revised (CRS-R) scale [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 [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 [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 [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

EEG recording in resting state with Phase Coherence analysis(PC index) [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) [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) [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) [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

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients ages 14 to 65 years old;
DOC patients, including vegetative state and minimally consciousness state.
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;
Written informed consent from patient families

Exclusion Criteria:

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