NCT04010838

Spinal Cord Stimulation in Patients With Disorders of Consciousness

Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorder of Consciousness
• Minimally Conscious State
• Vegetative State

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-12-31
• Completion: 2023-06-30
• First posted: 2019-07-08
• Last updated: 2019-07-08

Locations

1 site across 1 country: China