AI-Powered Closed-Loop Multielectrode Transcutaneous Spinal Cord Stimulation: Real-Time Adjustments for Enhanced Motor Recovery in Spinal Cord Injury (AIM RECOVER)
Trial ID: NCT07452133
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-05
Completion date: 2028-09
Sponsor: Singapore General Hospital
Conditions: Spinal Cord Injury
Interventions: Dynamic stimulation; Static stimulation
Locations: Singapore General Hospital
Countries: Singapore
Enrollment: 7
Age range: 21 Years - 75 Years
Sex: ALL

Summary:
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:
Inclusion Criteria:

Healthy volunteers:

1. Adults aged 21 years or older with the mental capacity to provide informed consent.
2. No prior diagnosis of neuromuscular or neurological conditions affecting the lower limbs.
3. Able to walk independently with a normal gait pattern, as confirmed by clinical observation done by the study team.

SCI patients:

1. Age 21 -75 years;
2. Non-progressive, incomplete SCI (traumatic or non-traumatic).
3. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) /ASIA Impairment scale (AIS) grade B, C, or D, with Lower Extremity Motor Scores (ISNCSCI-LEMS) less than or equal to 40;
4. Injury level at/above L1 (above conus medullaris) with intact segmental reflexes below level of lesion;
5. Able to provide informed consent;
6. No contraindication for tSCS, such as pace makers or other implantable electrical devices;
7. Eligible for body-weight support treadmill training;
8. Able to stand with body weight support and/or assistance.

Exclusion Criteria:

Healthy voluteers:

1. Presence of significant or unstable medical comorbidities, including uncontrolled cardiopulmonary disease or severe cognitive impairment, as determined by the study team.
2. Diagnosis of any neuromuscular or musculoskeletal disorders (e.g., congenital skeletal deformity, limb amputation, neurological disorders, myopathy).
3. Abnormal gait pattern due to underlying medical co-morbidities, as identified through physical examination and clinical assessment, and confirmed by the study team.
4. Current pregnancy.

SCI patients:

1. Significant or unstable medical co-morbidities, including uncontrolled cardiopulmonary disease, severe cognitive impairment, or severe dysautonomia, as determined by the study team;
2. Uncontrolled neuropathic or musculoskeletal pain, or contractures affecting participation in therapy;
3. Known history of peripheral nerve injury (e.g., traumatic nerve injury, entrapment neuropathy);
4. Pregnancy;
5. Active malignancy or ongoing cancer treatment;
6. Skin conditions (e.g., ulcers, infections, malignant lesions) that limit the application of tSCS electrodes;
7. Prior exposure to tSCS or eSCS interventions.

Outcomes:
Average maximal muscle amplitude (mV); Accuracy of Gait Phase Detection and Stimulation Synchronization (%)