Spinal Cord Stimulation in Patients With Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorder of Consciousness Minimally Conscious State Vegetative State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

People who involved with data analysis and outcomes assessment would be blind to the randomization procedure.

Study Groups

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Conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Spinal cord stimulation and conventional treatment

Group Type EXPERIMENTAL

spinal cord stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No