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AI-Guided Spatiotemporal Multi-Electrode Versus Single-Electrode Transcutaneous Spinal Cord Stimulation Combined With Gait Training in Individuals With Spinal Cord Injury or Stroke
Sponsor study identifier
Secondary identifiers
OTHER · Brazilian Research Ethics System (CEP/CONEP) - CAAE
interventional
24
1 country
1
Study Start
November 3, 2025
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to investigate whether personalized multi-electrode transcutaneous spinal cord stimulation (tSCS), guided by machine learning (ML) and combined with gait training, can improve walking function in people with spinal cord injury or stroke compared with single-electrode tonic stimulation combined with the same training. tSCS is a non-invasive technique that delivers electrical pulses through electrodes placed on the skin over the spine to modulate spinal neural circuits, facilitate the recruitment of lower-limb muscles, and support the recovery of voluntary movements. Conventional tSCS typically uses a single stimulation electrode, which may limit selective recruitment of different muscle groups. This study investigates a personalized multi-electrode approach to selectively recruit specific lower-limb muscle groups and deliver stimulation at appropriate phases of the gait cycle, with the aim of improving walking function. The main questions this study aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 3, 2025
Actual (reported)October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Comfortable overground walking speed will be assessed using the 10-Meter Walk Test (10MWT) and expressed in meters per second (m/s). Assistive devices and orthoses will be permitted and documented. Participants unable to complete the test due to insufficient walking ability will be assigned a value of 0 m/s for the primary analysis. This value represents inability to perform the test rather than a measured walking speed. The primary outcome will be the change in walking speed from baseline to completion of the intervention, compared between the single-electrode and multi-electrode tSCS groups. Assessment procedures will be standardized across visits.
Baseline (T0) and after 4 weeks of intervention (T1)
Change in Walking Ability Assessed by the Walking Index for Spinal Cord Injury II (WISCI II)
Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Lower-Limb Motor Function Assessed by the Fugl-Meyer Assessment (FMA-LE)
Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Lower-Limb Muscle Strength Assessed by the Medical Research Council (MRC) Scale
Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Lower-Limb Spasticity Assessed by the Modified Ashworth Scale (MAS)
Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Balance Assessed by the Berg Balance Scale (BBS)
Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Participants receive single-electrode tonic transcutaneous spinal cord stimulation (tSCS) combined with treadmill-based gait training. Before each training session, individualized stimulation calibration is performed in a supine position using muscle responses recorded by surface electromyography (EMG). A single electrode and stimulation intensity are selected to promote broad recruitment of lower-limb muscle groups rather than selective activation of individual muscle groups. During walking, tonic stimulation is delivered continuously through the selected electrode. Participants complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session, with individualized body-weight support and physical assistance as needed.
Participants receive personalized multi-electrode transcutaneous spinal cord stimulation (tSCS) combined with treadmill-based gait training. Before each training session, machine-learning-based optimization is performed in a supine position using muscle responses recorded by surface electromyography (EMG). Electrode configurations and stimulation intensities are individually selected to preferentially recruit specific lower-limb muscle groups, including proximal and distal muscles on both sides. During walking, wearable inertial sensors detect gait phases in real time, allowing the previously selected electrode configurations to be activated at the corresponding phases according to a predefined gait model. Participants complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session, with individualized body-weight support and physical assistance as needed.
Non-invasive transcutaneous spinal cord stimulation delivered through a single active spinal electrode. Before each gait-training session, individualized calibration is performed to select an electrode position and stimulation intensity intended to promote broad recruitment of lower-limb muscles, based on evoked muscle responses recorded by surface EMG. During treadmill walking, continuous tonic stimulation is delivered through the selected electrode, without phase-specific modulation.
Instituto de Medicina Física e Reabilitação (IMREA) - HCFMUSP
São Paulo, São Paulo, 04116-040, Brazil
Bryson N, Lombardi L, Hawthorn R, Fei J, Keesey R, Peiffer JD, Seanez I. Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. J Neural Eng. 2023 Jul 25;20(4):10.1088/1741-2552/ace552. doi: 10.1088/1741-2552/ace552.
Hofstoetter US, Freundl B, Binder H, Minassian K. Common neural structures activated by epidural and transcutaneous lumbar spinal cord stimulation: Elicitation of posterior root-muscle reflexes. PLoS One. 2018 Jan 30;13(1):e0192013. doi: 10.1371/journal.pone.0192013. eCollection 2018.
Mohamed Bouri, PhD
REHAssist - Ecole Polytechnique Fédérale de Lausanne (EPFL)
First Submitted
October 19, 2026
First Posted
October 26, 2026
Participants receive personalized multi-electrode transcutaneous spinal cord stimulation (tSCS) combined with treadmill-based gait training. Before each training session, machine-learning-based optimization is performed in a supine position using muscle responses recorded by surface electromyography (EMG). Electrode configurations and stimulation intensities are individually selected to preferentially recruit specific lower-limb muscle groups, including proximal and distal muscles on both sides. During walking, wearable inertial sensors detect gait phases in real time, allowing the previously selected electrode configurations to be activated at the corresponding phases according to a predefined gait model. Participants complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session, with individualized body-weight support and physical assistance as needed.
Contact the study team to confirm eligibility.
Hofstoetter US, Krenn M, Danner SM, Hofer C, Kern H, McKay WB, Mayr W, Minassian K. Augmentation of Voluntary Locomotor Activity by Transcutaneous Spinal Cord Stimulation in Motor-Incomplete Spinal Cord-Injured Individuals. Artif Organs. 2015 Oct;39(10):E176-86. doi: 10.1111/aor.12615. Epub 2015 Oct 6.
Calvert JS, Manson GA, Grahn PJ, Sayenko DG. Preferential activation of spinal sensorimotor networks via lateralized transcutaneous spinal stimulation in neurologically intact humans. J Neurophysiol. 2019 Nov 1;122(5):2111-2118. doi: 10.1152/jn.00454.2019. Epub 2019 Sep 25.
Zorkot M, Carpineto R, Shokur S, Micera S, Bouri M. Automated Selectivity-Driven Algorithm for Transcutaneous Spinal Cord Stimulation. IEEE Int Conf Rehabil Robot. 2025 May;2025:989-994. doi: 10.1109/ICORR66766.2025.11063011.
Study Start
November 3, 2025
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
Individual participant data (IPD) will not be shared publicly due to the sensitive nature of the clinical and neurophysiological data collected from participants with spinal cord injury and stroke, as well as the potential risk of participant re-identification given the relatively small study population. Study findings will be disseminated through scientific publications and presentations using aggregated, non-identifiable data.
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Source: ClinicalTrials.gov.
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