About this trial
Spinal cord injury (SCI) often results in persistent motor deficits that are inadequately addressed by conventional rehabilitation. Transcutaneous spinal cord stimulation (tSCS) is a promising non-invasive neuromodulatory approach that can enhance motor activation and gait performance; however, current tSCS systems rely on static, pre-programmed stimulation parameters that do not adapt to real-time motor output or task demands. This limitation may reduce muscle selectivity and disrupt the spatiotemporal dynamics of spinal network activation required for functional movement.
This study aims to develop and evaluate an AI-powered closed-loop multielectrode tSCS system that dynamically adjusts stimulation parameters in real time based on kinematic and surface electromyography (EMG) feedback during walking in individuals with incomplete SCI. The study will compare immediate muscle recruitment and motor performance between conventional static tSCS and dynamic, targeted tSCS guided by real-time physiological signals.
The investigators hypothesize that AI-driven closed-loop tSCS will be safe and feasible, and will result in superior muscle activation patterns and improved gait performance compared with static stimulation. Findings from this study will provide foundational evidence for adaptive neuromodulation strategies and support the advancement of next-generation, data-driven spinal cord stimulation technologies for neurorehabilitation in SCI.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 21 years or older with the mental capacity to provide informed consent.
No prior diagnosis of neuromuscular or neurological conditions affecting the lower limbs.
Able to walk independently with a normal gait pattern, as confirmed by clinical observation done by the study team.
Age 21 -75 years;
Disqualifiers
Presence of significant or unstable medical comorbidities, including uncontrolled cardiopulmonary disease or severe cognitive impairment, as determined by the study team.
Diagnosis of any neuromuscular or musculoskeletal disorders (e.g., congenital skeletal deformity, limb amputation, neurological disorders, myopathy).
Abnormal gait pattern due to underlying medical co-morbidities, as identified through physical examination and clinical assessment, and confirmed by the study team.
Current pregnancy.
Trial design
Parallel
Treatments tested in this trial
Dynamic stimulation
DeviceMultielectrode transcutaneous spinal cord stimulation with real-time spatiotemporal modulation
Static stimulation
DevicetSCS delivered via a single midline electrode positioned over the thoracolumbar region (T11-T12). Stimulation is delivered in a continuous mode
Treatment groups
Trial outcomes
Primary outcomes
Average maximal muscle amplitude (mV)
Maximal muscle amplitude of key muscles (bilateral knee extensors, ankle dorsiflexors), recorded from myoMUSCLE analysis report.
Accuracy of Gait Phase Detection and Stimulation Synchronization (%)
Percentage of accurate stimulation intensity delivery in SCI patients during every gait cycle
Secondary outcomes
Gait curve analysis (joint angles of lower limbs)
From Noraxon software gait analysis report
Gait phase, spatial, and time parameters
From Noraxon software gait analysis report
Safety monitoring
All adverse events
Sponsors and contacts
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