Clinical trial NCT04010838: Spinal Cord Stimulation in Patients With Disorders of Consciousness
Official title: Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Consciousness
Minimally Conscious State
Vegetative State
Keywords: disorders of consciousness
spinal cord stimulation
DoC
SCS
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: at baseline (T0), which means 1 month before stimulation.
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: 2 weeks after the end of the treatment (T1)
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: 3 months after the end of the treatment (T2)
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: 6 months after the end of the treatment(T3)
Secondary outcomes:
measure: EEG recording in resting state with Phase Coherence analysis(PC index)
timeFrame: at baseline (T0), which means 1 month before stimulation.
measure: EEG recording in resting state with Phase Coherence analysis(PC index)
timeFrame: 2 weeks after the end of the treatment (T1)
measure: EEG recording in resting state with Phase Coherence analysis(PC index)
timeFrame: 3 months after the end of the treatment (T2)
measure: EEG recording in resting state with Phase Coherence analysis(PC index)
timeFrame: 6 months after the end of the treatment (T3)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital
state: Shanghai
Study officials:
References: