NCT06515132

Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation

Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorder of Consciousness
• Spinal Cord Stimulation

Interventions

Type	Name	Description
PROCEDURE	SCS Stimulation	Participants will accept the SCS stimulus for six months
PROCEDURE	Sham Stimulation	Sham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-12-30
• Completion: 2026-05-30
• First posted: 2024-07-23
• Last updated: 2025-01-07

Locations

3 sites across 1 country: China