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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorSingapore General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

7 Participants
are divided into 2 treatment groups
Group A: Conventional stimulationActive comparator 1 intervention
Group B: Multielectrode dynamic stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average maximal muscle amplitude (mV)

Maximal muscle amplitude of key muscles (bilateral knee extensors, ankle dorsiflexors), recorded from myoMUSCLE analysis report.

Time frame
Measured during Step 2 (Spatiotemporal Mapping Phase); collected across at least 3 separate days (approximately 1-2 weeks per participant)
2

Accuracy of Gait Phase Detection and Stimulation Synchronization (%)

Percentage of accurate stimulation intensity delivery in SCI patients during every gait cycle

Time frame
Measured during Step 3 (Closed-Loop Development Phase); assessed every gait cycle across approximately 1000 gait cycles (~5 sessions, total ~300 minutes)

Secondary outcomes

1

Gait curve analysis (joint angles of lower limbs)

From Noraxon software gait analysis report

Time frame
Measured during Step 1 (Baseline) and during Step 3 (Closed-Loop Sessions); approximately 100 gait cycles at baseline and repeated across closed-loop sessions (~5 sessions), approximately 2-4 weeks total participation
2

Gait phase, spatial, and time parameters

From Noraxon software gait analysis report

Time frame
From baseline until the end of study intervention at step 3, approximately 2-4 weeks total participation
3

Safety monitoring

All adverse events

Time frame
Every session and at approximate 4 to 6 weeks after intervention

Other outcomes

Sponsors and contacts

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