AI-Powered Closed-Loop Multielectrode Transcutaneous Spinal Cord Stimulation: Real-Time Adjustments for Enhanced Motor Recovery in Spinal Cord Injury (AIM RECOVER)

Sponsor
Singapore General Hospital
Study ID
NCT07452133
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dynamic stimulation — DEVICE
    Multielectrode transcutaneous spinal cord stimulation with real-time spatiotemporal modulation
  • Static stimulation — DEVICE
    tSCS delivered via a single midline electrode positioned over the thoracolumbar region (T11-T12). Stimulation is delivered in a continuous mode

Study Details

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.

Key Dates

First listed
Mar 5, 2026
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
7 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional stimulation
    Conventional single-electrode continuous transcutaneous spinal cord stimulation (static tSCS)
  • Experimental: Multielectrode dynamic stimulation
    Continuous midline stimulation with concurrent lateral electrode activation targeting the relevant nerve root during voluntary movement attempts (dynamic tSCS)

Primary Outcome Measure

Average maximal muscle amplitude (mV) [ Time Frame: Measured during Step 2 (Spatiotemporal Mapping Phase); collected across at least 3 separate days (approximately 1-2 weeks per participant) ]

Central Contacts

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