Spinal Cord Stimulation in Patients With Disorders of Consciousness

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04010838
Study type	Interventional
Source	Huashan Hospital
Contact	Xuehai Wu, Ph.D.
Phone	+8613764880571
Email	wuxuehai2013@163.com
Status	Recruiting
Phase	N/A
Start date	July 1, 2019
Completion date	June 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05954650` - Clinical Validity of the Minimally Conscious State "Plus" and "Minus"
Suspended	`NCT04244058` - Changes in Glutamatergic Neurotransmission of Severe TBI Patients	Early Phase 1
Recruiting	`NCT05285124` - HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness	N/A
Not yet recruiting	`NCT05833568` - Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness	N/A
Recruiting	`NCT05219331` - Hydrocephalus Treatment on Persistent Disorder of Consciousness	N/A
Recruiting	`NCT05706831` - Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases	N/A
Completed	`NCT03114397` - Long-term Effect of tDCS in Patients With Disorders of Consciousness	N/A
Active, not recruiting	`NCT03623828` - Treating Severe Brain-injured Patients With Apomorphine	Phase 2
Active, not recruiting	`NCT05734183` - Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness	N/A
Recruiting	`NCT05714215` - SECONDs' Italian Translation and Transcultural Validation
Completed	`NCT04035655` - Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session	N/A
Active, not recruiting	`NCT05747170` - Olfactory Stimulation in Severe Brain Injury	N/A
Active, not recruiting	`NCT03826407` - Development of a Point of Care System for Automated Coma Prognosis
Recruiting	`NCT03576248` - CONsciousness Transcranial Electric STimulation	N/A
Recruiting	`NCT03611166` - Proteomics for Chronic Disorder of Consciousness
Recruiting	`NCT05382260` - Personal Music for Disorders of Consciousness	N/A
Not yet recruiting	`NCT05820178` - tDCS and rTMS in Patients With Early Disorders of Consciousness	N/A
Recruiting	`NCT05343507` - Ketamine to Treat Patients With Post-comatose Disorders of Consciousness	Phase 2/Phase 3
Completed	`NCT05536921` - Eye Tracking Technology in the Diagnosis of Neurological Patients
Completed	`NCT02647996` - Functional Connectivity Measurement After Severe Traumatic Brain Injury

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.