Initial feasibility evaluation of the RISES system: An innovative and activity-based closed-loop framework for spinal cord injury rehabilitation and recovery

Journal of Rehabilitation and Assistive Technologies Engineering, 2024 · DOI: 10.1177/20556683241280242 · Published: August 19, 2024

Spinal Cord Injury Neurology Biomedical

Simple Explanation

This study introduces the Reynolds Innovative Spinal Electrical Stimulation (RISES) system, a novel technology that uses transcutaneous spinal cord stimulation (tSCS) in a closed-loop setting to aid in spinal cord injury (SCI) rehabilitation. The system adjusts stimulation parameters in real-time based on a person's movement. The RISES system has two modes: open-loop, which delivers stimulation with fixed parameters at predetermined time intervals, and closed-loop, which continuously updates stimulation parameters in real-time based on the person's movement execution. This real-time adjustment aims to optimize stimulation for each individual and their specific tasks. The study primarily focused on assessing the safety and feasibility of the RISES system, especially its closed-loop mode, in a clinical trial involving functional task practice (FTP) for rehabilitation. It compared the closed-loop approach to the conventional open-loop method.

Study Duration

3 Months

Participants

4 SCI participants

Evidence Level

Not specified

Key Findings

1
The RISES system demonstrated safety and feasibility for tSCS application in clinical settings. There were no serious adverse events and skin integrity was unaffected at stimulation sites.
2
Fatigue levels increased across the three time-points of each intervention session regardless of stimulation block. This highlights potential as a risk factor in similar studies.
3
Normalized stimulation time analysis showed a significant Mode effect, with Open-loop having a higher mean duration than Closed-loop per task.

Research Summary

This study evaluated the safety and feasibility of the Reynolds Innovative Spinal Electrical Stimulation (RISES) system, a novel closed-loop transcutaneous spinal cord stimulation (tSCS) technology for spinal cord injury (SCI) rehabilitation. The RISES system offers real-time stimulation parameter modulation and supports multi-data acquisition and storage. Four participants with chronic cervical SCI underwent a clinical trial coupled with activity-based training. The study assessed adverse events, skin integrity, vital signs, pain, and fatigue during open-loop and closed-loop tSCS blocks. The RISES system demonstrated safety and feasibility, with no serious adverse events and unaffected skin integrity at stimulation sites. Further research will focus on clinical efficacy.

Practical Implications

Clinical Application

The RISES system shows promise as a safe and feasible tool for incorporating tSCS into SCI rehabilitation, offering personalized and task-specific stimulation.

Research Advancement

The RISES system provides a platform for integrating wearable sensors, allowing for objective measurement of neurophysiological and kinematic responses, enhancing understanding of tSCS mechanisms.

Personalized Rehabilitation

The closed-loop stimulation mode allows for tailoring stimulation parameters to individual patient needs and injury levels, potentially optimizing rehabilitation outcomes.

Study Limitations

1
Small sample size
2
Non-randomized single group repeated measures design
3
Potential carryover effects between open-loop and closed-loop stimulation blocks

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