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

NCT07452133 | Not Yet Recruiting

• 1 other identifier: 2025-1393
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Transcutaneous Spinal Cord Stimulation (tSCS); Closed-Loop Neuromodulation; Artificial Intelligence; Wearable Sensors; Neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• Average maximal muscle amplitude (mV)

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

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

• Accuracy of Gait Phase Detection and Stimulation Synchronization (%)

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

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

Secondary Outcomes (3)

• Gait curve analysis (joint angles of lower limbs)

  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

• Gait phase, spatial, and time parameters

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

• Safety monitoring

  Every session and at approximate 4 to 6 weeks after intervention

Study Arms (2)

Conventional stimulation

ACTIVE COMPARATOR

Conventional single-electrode continuous transcutaneous spinal cord stimulation (static tSCS)

Device: Static stimulation

Multielectrode dynamic stimulation

EXPERIMENTAL

Continuous midline stimulation with concurrent lateral electrode activation targeting the relevant nerve root during voluntary movement attempts (dynamic tSCS)

Device: Dynamic stimulation

Interventions

Dynamic stimulation DEVICE

Multielectrode transcutaneous spinal cord stimulation with real-time spatiotemporal modulation

Multielectrode dynamic stimulation

Static stimulation DEVICE

tSCS delivered via a single midline electrode positioned over the thoracolumbar region (T11-T12). Stimulation is delivered in a continuous mode

Conventional stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• 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.
• SCI patients:
• Age 21 -75 years;
• Non-progressive, incomplete SCI (traumatic or non-traumatic).
• 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;
• Injury level at/above L1 (above conus medullaris) with intact segmental reflexes below level of lesion;
• Able to provide informed consent;
• No contraindication for tSCS, such as pace makers or other implantable electrical devices;
• Eligible for body-weight support treadmill training;
• Able to stand with body weight support and/or assistance.

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jing Chen, MD

CONTACT

+6565762049; chen.jing@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study using a within-subject, alternating-treatments and single-case experimental design. Participants receive both stimulation conditions (static single-electrode tSCS and multielectrode dynamic tSCS) in a randomized sequence, allowing direct comparison of muscle recruitment and gait performance within the same individual. The study also includes a developmental phase for an AI-powered closed-loop control system using real-time kinematic and EMG feedback.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: March 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

SG (1)