NCT06881134

Rehabilitation Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton After Spinal Cord Injury

Combinative Rehabilitation Strategy Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton (SCS-EXS) After Spinal Cord Injury: An Exploratory Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Spinal cord injury (SCI) can be caused by trauma, inflammation, tumors, and other factors, often leading to issues such as impaired leg movement, abnormal sensation, and difficulties with bladder and bowel control. These challenges significantly affect the patient's quality of life. While there is currently no cure for spinal cord injury, the latest guidelines recommend spinal cord stimulation and robotic exoskeletons as effective rehabilitation methods. Spinal cord stimulation (SCS) involves implanting a device that delivers electrical stimulations to aid in motor function recovery. Its safety and effectiveness have been proven in multiple clinical studies. For example, in 2022, a Swiss research team successfully helped three patients with severe spinal cord injuries regain the ability to stand, walk, and perform other movements, offering new hope for recovery. A robotic exoskeleton is a wearable device that assists patients in movements like walking while promoting nerve and muscle recovery. This technology has become an increasingly important tool in spinal cord injury rehabilitation. Recent studies have shown that combining spinal cord stimulation and robotic exoskeletons yields better outcomes. For instance, in 2023, an American research team demonstrated that after 24 weeks of combined therapy, patients could achieve independent walking or walk with the aid of assistive devices. This study aims to combine spinal cord stimulation with robotic exoskeleton therapy to develop personalized rehabilitation plans for patients. The goal is to restore lower limb motor function and improve long-term quality of life.

Detailed description

Spinal cord injury (SCI) often results in long-term impairments in motor, sensory, and autonomic nervous functions, significantly reducing patients' quality of life and increasing the burden on families and society. Spinal cord stimulation (SCS) has emerged in recent years as a key therapeutic tool for functional rehabilitation following SCI. Multiple clinical research has confirmed its safety and effectiveness. Chalif et al. evaluated the applications of SCS in managing chronic SCI in a systematic review, highlighting its potential not only for motor function rehabilitation but also for improving bladder and bowel functions, regulating respiratory pressures, and enhancing gastrointestinal motility. On the other hand, robotic exoskeleton as an innovative rehabilitation device, has demonstrated great potential in the treatment of SCI. By providing mechanical support, robotic exoskeletons assist patients in movement training, thereby promoting neural recovery and strengthening muscle function. Numerous clinical studies have investigated the benefits of exoskeleton training for lower limb rehabilitation in SCI patients, with results showing significant improvements in walking speed and independence. Future studies should explore the combination of exoskeleton training with other rehabilitation modalities to optimize outcomes and provide more robust clinical guidance. The combination of SCS and robotic exoskeletons represents a novel direction in motor recovery for SCI. This approach aims to activate spinal neurons via SCS to restore muscle and neural functions, while robotic exoskeletons offer gait support and assist in motor activities, providing sensory feedback to construct a complete motor-sensory loop. This combination also holds promise for spinal circuit reorganization following SCI. Gorgey et al. reported three cases in 2020 and 2023 involving epidural spinal cord stimulation (eSCS) combined with exoskeleton training. The researchers identified optimal muscle activation parameters for walking and conducted 24 weeks of gait training with concurrent stimulation and exoskeleton use, achieving enhanced rehabilitation outcomes through this synergistic approach. Currently, research on the combination of SCS and robotic exoskeletons for lower limb rehabilitation is limited. There is a lack of large-scale, long-term studies to validate the sustained efficacy of this combined approach. To address this gap, our study aims to develop an innovative rehabilitation system combining spatiotemporal spinal cord stimulation with real-time triggering exoskeleton. This research seeks to integrate the two systems clinically, assess their safety and effectiveness, and design personalized strategies to maximize patients' rehabilitation outcomes.

Conditions

• Spinal Cord Injury
• Neuromodulation
• Robot Assisted Gait Training

Interventions

Type	Name	Description
DEVICE	SCS+EXS	Eligible participants will undergo implantation of the spinal cord stimulation (SCS) system. Intraoperative electrophysiological monitoring will be used to adjust stimulation parameters. SCS will be tested postoperatively to assess the patient's tolerance to stimulation and its therapeutic effects. Parameters designed to improve sensory function and bladder/bowel control will be established. All parameters will be integrated into a sequential stimulation protocol. Additionally, the simultaneous activation of the SCS and the robotic exoskeleton will be tested to ensure smooth integration. Exoskeleton-assisted training will be conducted for no less than 1 hour per day (divided into two 30-minute sessions). Other rehabilitation interventions will be provided for at least 3 hours per day. Follow-ups will be conducted at 1, 2, 3, 6, and 12 months postoperatively.

Timeline

• Start date: 2024-10-13
• Primary completion: 2026-01-01
• Completion: 2026-03-19
• First posted: 2025-03-18
• Last updated: 2026-03-20

Locations

1 site across 1 country: China