Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515132
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-23
Brief Title:
Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness A Multicenter Double-blind Randomized Controlled Trail
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCORS-DOC
Brief Summary:
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness
Detailed Description:
Disorder of Consciousness DOC is a highly significant and concerning consequence that frequently ensues various acute brain injuries The DOC encompasses coma unresponsive wakefulness syndrome UWS also known as persistent vegetative state PVS and minimally conscious state MCS Currently the available treatments for arousing patients with DOC are relatively limited encompassing pharmacotherapy hyperbaric oxygen therapy neuromodulation physical rehabilitation exercises and traditional Chinese acupuncture Among these approaches only amantadine and transcranial direct current stimulation have demonstrated efficacy in DOC patients however further extensive validation is still warranted
In recent years spinal cord stimulation SCS has emerged as a cutting-edge and extensively researched modality for arousal therapy SCS is a form of neuromodulation therapy primarily utilized for intractable pain diabetic neuropathy and muscle spasticity the therapeutic efficacy of the SCS is both significant and safe Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC these findings are currently limited to small sample reports Therefore this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management
In recent years spinal cord stimulation SCS has emerged as a cutting-edge and extensively researched modality for arousal therapy SCS is a form of neuromodulation therapy primarily utilized for intractable pain diabetic neuropathy and muscle spasticity the therapeutic efficacy of the SCS is both significant and safe Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC these findings are currently limited to small sample reports Therefore this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None