Spinal Cord Injuries (SCI)NCT07895888
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
A study testing Single-Electrode Tonic tSCS and Multi-Electrode Spatiotemporal tSCS in people with Spinal Cord Injuries (SCI), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Single-Electrode Tonic tSCS and Multi-Electrode Spatiotemporal tSCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Nov 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Criteria:
- Adults aged 18 to 65 years.
- Individuals with walking impairment associated with spinal cord injury (SCI) or stroke, including ambulatory and non-ambulatory participants.
- Provision of written informed consent.
- Spinal Cord Injury:
- Traumatic spinal cord injury.
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- SCI diagnosis at least 3 months before enrollment.
- American Spinal Injury Association Impairment Scale (AIS) classification B, C, or D.
- Stroke:
- Confirmed diagnosis of ischemic or hemorrhagic stroke.
- Hip flexor muscle strength of at least grade 2 on the Medical Research Council (MRC) scale in the paretic lower limb.
Who cannot join
- Cognitive impairment interfering with the ability to understand and follow simple instructions.
- Neurodegenerative diseases.
- Severe cardiovascular conditions that contraindicate physical exercise.
- Osteoporotic fractures or severe osteoporosis associated with a high risk of fracture.
- Body weight exceeding 120 kg.
- Pregnancy.
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- Spasticity graded 3 or higher on the Modified Ashworth Scale.
- Skin wounds or lesions at the planned electrode or sensor placement sites.
- Contraindications to transcutaneous electrical stimulation, including implanted electronic devices such as cardiac pacemakers, or other implants considered incompatible with electrical stimulation following an individualized safety assessment. Inert metallic implants are not automatically exclusionary.
- Leg length discrepancy.
- Heterotopic ossification that prevents movement.
- Cranial bone defects involving the cranial vault.
- Absence of adequate trunk control.
- Inability to evoke the required posterior root-muscle (PRM) reflex responses in the bilateral quadriceps muscles during screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto de Medicina Física e Reabilitação (IMREA) - HCFMUSP
São Paulo, São Paulo, 04116-040
About this study
Official title: AI-Guided Spatiotemporal Multi-Electrode Versus Single-Electrode Transcutaneous Spinal Cord Stimulation Combined With Gait Training in Individuals With Spinal Cord Injury or Stroke
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.
Read more
The main questions this study aims to answer are:
- How do electrode positions and stimulation intensities affect selective muscle recruitment, and how do responses vary between participants and days?
- Can ML-based optimization identify stimulation settings with selectivity comparable to complete mapping of muscle responses, using fewer tests and less time?
- Does personalized multi-electrode stimulation, synchronized with specific gait phases, improve walking function more than single-electrode tonic stimulation when both are combined with gait training?
The study includes 24 participants (14 with spinal cord injury and 10 with stroke) and consists of two stages.
Stage 1 - Characterization of tSCS Selectivity and Stimulation Optimization
All participants complete two experimental sessions while lying down. Researchers compare muscle responses to stimulation at a central electrode and at multiple spinal electrode locations. Electrical responses in the leg muscles are recorded using surface electromyography (EMG), and spinal reflexes are assessed using paired electrical pulses.
By systematically testing electrode positions and stimulation intensities, researchers build a map of which leg muscles respond to each setting (stimulation landscape). They assess the selective recruitment of different muscle groups, compare stimulation locations, and examine differences between participants and across the two sessions. They also test whether ML-based optimization can find similarly selective settings more efficiently than the complete mapping procedure.
Stage 2 - tSCS Combined With Gait Training
Participants are randomly assigned to one of two groups: single-electrode or multi-electrode tSCS, both combined with gait training. During spinal cord injury recruitment, the randomization procedure was adapted to better balance participants with different baseline walking abilities across groups.
Before each training session, participants lie down for an individualized calibration. An ML-based optimization method uses recorded muscle responses to select electrode positions and stimulation intensities for the subsequent walking session.
During walking, the single-electrode group receives continuous stimulation through one selected electrode. In the multi-electrode group, stimulation is delivered through electrodes selected to preferentially recruit different target muscle groups. A predefined walking-cycle model determines when stimulation should be delivered, based on gait phases detected in real time by wearable movement sensors.
Both groups complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session. Walking speed is selected according to each participant's comfort and ability, with therapist adjustments, body-weight support, and physical assistance as needed.
Clinical and functional assessments are conducted before the intervention (T0), after the 20 sessions (T1), and at a 30-day follow-up (T2). They examine walking performance, muscle strength, spasticity, balance, and mobility. Additional measurements assess muscle activation, brain activity, and biological markers associated with neuroplasticity. The follow-up assesses whether changes are maintained after training.
Read the detailed description
Background and Rationale
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation approach that modulates spinal sensorimotor circuits through the recruitment of afferent fibers. When combined with rehabilitation, tSCS may facilitate voluntary motor control and functional recovery in individuals with spinal cord injury (SCI) or stroke.
Conventional tSCS commonly applies tonic stimulation through a single electrode, which may limit the ability to preferentially recruit specific lower-limb muscle groups. This study investigates a personalized multi-electrode approach combining machine-learning (ML)-based optimization of stimulation settings with a predefined feedforward strategy that coordinates stimulation with the walking cycle. Stimulation configurations are selected according to individual muscle responses during calibration and then activated according to gait phases detected during walking.
The study has three objectives: (1) to assess the selectivity of tSCS and characterize the spatial distribution and between-participant and between-session variability of muscle recruitment; (2) to assess whether ML-based optimization identifies selective stimulation configurations more efficiently than systematic mapping of muscle responses; and (3) to compare changes in walking function following multi-electrode versus single-electrode tonic tSCS, both combined with gait training.
Study Design
This is a prospective, controlled, randomized, parallel-group interventional study involving 24 participants, including 14 with SCI and 10 with stroke. The protocol includes two sequential stages: electrophysiological characterization and stimulation optimization, followed by a gait-training intervention.
All participants undergo the first stage. For the second stage, participants are assigned to one of two intervention groups: single-electrode or multi-electrode tSCS, both combined with gait training.
The initial allocation procedure used simple randomization. During SCI recruitment, stratified randomization based on baseline walking ability (ambulatory or non-ambulatory) was introduced to improve balance between the intervention groups. The SCI sample size was increased to 14 participants. Each participant receives only one of the two interventions throughout the training program.
Stage 1 - Characterization of tSCS Selectivity and ML-Based Optimization
All participants complete two sessions in a supine position to examine muscle recruitment selectivity and the reproducibility of responses across days.
Stimulation is tested using a central spinal electrode and multiple electrode locations over the thoracolumbar region. Posterior root-muscle (PRM) reflexes are assessed with paired-pulse stimulation, and evoked responses are recorded bilaterally by surface electromyography (EMG).
Systematic testing of electrode positions and stimulation intensities is used to construct individual stimulation landscapes. These maps describe the distribution of evoked lower-limb muscle responses across stimulation settings, with particular attention to four target groups: left proximal, right proximal, left distal, and right distal muscles. They are used to compare recruitment selectivity between stimulation configurations and to examine variability between participants and between the two sessions.
An ML-based optimization method is evaluated for identifying settings that preferentially recruit target muscle groups. Its results are compared with the comprehensive stimulation landscapes, focusing on achieved selectivity, the number of stimulation tests needed, and the time required to identify suitable configurations.
Stage 2 - tSCS Combined With Gait Training
Participants complete 20 supervised gait-training sessions over four weeks (five sessions per week). Each session includes a supine calibration procedure before gait training. Muscle responses recorded during electrical stimulation are used by the ML-based method to select individualized electrode positions and stimulation intensities. This repeated calibration allows settings to be adapted to day-to-day differences in responses.
Single-Electrode tSCS
For the single-electrode intervention, calibration identifies a stimulation electrode and intensity intended to recruit lower-limb muscles broadly. During gait training, continuous tonic stimulation is delivered through the selected electrode.
Multi-Electrode tSCS
For the multi-electrode intervention, calibration identifies configurations that preferentially recruit different target muscle groups. A predefined feedforward gait model specifies when each configuration should be activated during the walking cycle. Wearable inertial measurement units (IMUs) detect gait phases in real time, and the stimulation system uses this information to deliver the previously selected stimulation patterns at the corresponding phases. Optimization of stimulation settings is performed before, rather than during, walking.
Gait Training Procedure
Both groups receive 30 minutes of treadmill-based gait training per session with a body-weight support system. Participants walk at a comfortable, self-selected speed, with therapist adjustments when necessary. Body-weight support and additional physical assistance are adapted to each participant's functional abilities and safety needs.
Clinical, Biomechanical, and Neurophysiological Assessments
Clinical and functional evaluations take place before the intervention (T0), after completion of the 20 training sessions (T1), and at a 30-day follow-up (T2). The main intervention comparisons focus on changes from T0 to T1; T2 is used to examine the maintenance of changes after training.
Functional assessments cover walking performance and independence, mobility, balance, lower-limb strength, and spasticity. Measures include the 10-Meter Walk Test (10MWT), Timed Up and Go (TUG), Berg Balance Scale, Medical Research Council muscle strength scale, and Modified Ashworth Scale, together with population-specific assessments such as the Walking Index for Spinal Cord Injury II (WISCI II) and the Fugl-Meyer Assessment of the Lower Extremity. Assessments are performed according to each participant's functional abilities.
Surface EMG and wearable sensors assess muscle activity and gait characteristics. Three-dimensional motion capture is used when feasible according to the participant's walking ability. Additional investigations include electroencephalography (EEG) for cortical activity, functional near-infrared spectroscopy (fNIRS) for cortical hemodynamic responses, and blood-based analyses of brain-derived neurotrophic factor (BDNF) and genetic variants related to neuroplasticity. The timing of these measurements follows the schedule for each assessment modality.
The study aims to provide evidence on muscle recruitment selectivity, the efficiency of ML-guided calibration, and the functional and physiological effects of personalized multi-electrode tSCS for gait rehabilitation in SCI and stroke.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Single-Electrode Tonic tSCS, Multi-Electrode Spatiotemporal tSCS
- Keywords
- Transcutaneous Spinal Cord Stimulation, Multi-Electrode tSCS, Machine Learning, Personalized Neuromodulation, Spatiotemporal tSCS, Gait Rehabilitation, Neurorehabilitation, Muscle Recruitment Selectivity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Electrode Tonic tSCSDevice
Also called tSCS
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.
Multi-Electrode Spatiotemporal tSCSDevice
Also called spatio-temporal tSCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Electrode tSCS + Gait Training | Active comparator | 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. Receives: Device: Single-Electrode Tonic tSCS |
| Multi-Electrode tSCS + Gait Training | Experimental | 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. Receives: Device: Multi-Electrode Spatiotemporal tSCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and after 4 weeks of intervention (T1)
Secondary outcomes (17)
Change in Walking Ability Assessed by the Walking Index for Spinal Cord Injury II (WISCI II)
Walking ability in participants with spinal cord injury will be assessed using the Walking Index for Spinal Cord Injury II (WISCI II). The scale ranges from 0 to 20 and classifies walking performance according to the need for physical assistance, assistive devices, and orthoses. Higher scores indicate greater walking ability. Changes in WISCI II scores will be evaluated across assessment visits.
Measured: 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)
Lower-limb motor function in participants with stroke will be assessed using the lower-extremity motor subscale of the Fugl-Meyer Assessment (FMA-LE). Motor scores range from 0 to 34, with higher scores indicating better motor function. Changes in FMA-LE motor scores will be evaluated across assessment visits.
Measured: 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
Lower-limb muscle strength will be assessed using the Medical Research Council (MRC) scale. Individual muscle groups will be graded from 0 (no visible muscle contraction) to 5 (normal muscle strength). Changes in muscle strength will be evaluated in participants with spinal cord injury and stroke. Scores for the assessed muscle groups will be reported separately rather than combined into an unspecified composite score.
Measured: 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)
Resistance to passive movement in lower-limb muscle groups will be assessed using the Modified Ashworth Scale (MAS). The scale includes the ordinal grades 0, 1, 1+, 2, 3, and 4, with higher grades indicating greater resistance to passive movement. Changes in MAS grades will be evaluated for the assessed muscle groups without combining them into an unspecified total score-
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Balance Assessed by the Berg Balance Scale (BBS)
Balance performance will be evaluated using the Berg Balance Scale (BBS), which includes 14 tasks assessing static and dynamic balance. Total scores range from 0 to 56, with higher scores indicating better balance performance. Changes in total BBS scores will be evaluated across assessment visits.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Functional Mobility Assessed by the Timed Up and Go Test (TUG)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The test measures the time, in seconds, required to stand from a chair, walk 3 meters, turn around, return to the chair, and sit down. Lower completion times indicate better functional mobility. Assistive devices may be used as needed and will be documented. Participants unable to complete the test will be recorded as unable to perform the assessment rather than assigned an arbitrary completion time.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Walking Speed at 30-Day Follow-Up Assessed by the 10MWT
Comfortable overground walking speed will be assessed using the 10-Meter Walk Test (10MWT) and expressed in meters per second (m/s). The outcome will be the change in walking speed from baseline to the 30-day follow-up after completion of the intervention. The same assessment procedures, documentation of assistive devices, and scoring rules defined for the primary outcome will be applied.
Measured: Baseline (T0) and 30-day follow-up after completion of the intervention (T2)
Gait-Phase-Dependent Muscle Activation Assessed by the Phase Selectivity Index (PSI)
Gait-phase-dependent muscle activation will be assessed using surface electromyography (EMG) recorded bilaterally from lower-limb muscles. The Phase Selectivity Index (PSI) will be calculated from the root mean square (RMS) EMG amplitude during the target gait phase relative to the non-target phase. PSI ranges from -100% to 100%, with higher values indicating greater preferential activation during the intended gait phase. Values will be evaluated for individual recorded muscles to characterize the temporal coordination of muscle activation during walking.
Measured: During the first and twentieth gait-training sessions (approximately 4 weeks apart)
Change in Spatial Gait Parameters Assessed by Instrumented Gait Analysis
Spatial gait characteristics will be evaluated using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Measures include step length, stride length, and step width, all expressed in centimeters (cm). These parameters characterize the spatial dimensions of gait and will be examined as separate component measures, without calculation of a composite score. Bilateral measurements will be retained when available.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Walking Speed Assessed by Instrumented Gait Analysis
Walking speed will be evaluated during instrumented gait analysis using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Speed will be expressed in centimeters per second (cm/s). This laboratory-based measure characterizes walking performance under the standardized gait assessment conditions and will be analyzed separately from the overground 10-Meter Walk Test.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Gait Cadence Assessed by Instrumented Gait Analysis
Gait cadence will be evaluated using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Cadence will be expressed in steps per minute and represents the number of steps performed per unit of time. Changes in gait cadence will be used to characterize temporal aspects of walking performance.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Temporal Gait Phase Parameters Assessed by Instrumented Gait Analysis
Temporal gait characteristics will be assessed using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Measures include stance phase duration, swing phase duration, initial double-support duration, and single-support duration. Each parameter will be expressed as a percentage of the gait cycle (%). These measures characterize the distribution of time across gait phases and will be evaluated as separate components rather than combined into a composite score.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Resting-State EEG Spectral Power
Resting-state cortical activity will be assessed using electroencephalography (EEG) under eyes-open and eyes-closed conditions. Power spectral density will be calculated in predefined frequency bands (delta, theta, alpha, beta, and gamma) to quantify cortical oscillatory activity. Spectral power will be assessed separately by frequency band and recording condition, with comparisons of cortical activity across assessment visits.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Cortical Hemodynamic Response Assessed by fNIRS
Task-related cortical hemodynamic activity during gait training will be assessed using functional near-infrared spectroscopy (fNIRS). Changes in oxygenated hemoglobin (HbO) concentration will be estimated using a general linear model (GLM) in predefined cortical regions of interest involved in motor control. The HbO hemodynamic response will be used to assess changes in cortical activation associated with gait training.
Measured: During the first and twentieth gait-training sessions (approximately 4 weeks apart)
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Serum brain-derived neurotrophic factor (BDNF) concentration will be quantified from peripheral blood samples using an immunoassay. Concentrations will be reported using the laboratory assay's specified units. Changes in serum BDNF concentration will be evaluated across assessment visits and compared between intervention groups as a circulating biomarker potentially associated with neuroplasticity.
Measured: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Body-Weight Support During Treadmill Gait Training
The amount of body-weight support provided during treadmill gait training will be recorded as a percentage of the participant's body weight (%). Lower percentages indicate reduced reliance on external body-weight support. Changes in the level of support used during training will be evaluated to characterize progression in weight-bearing capacity and walking performance.
Measured: During the 20 gait-training sessions over 4 weeks
Change in Treadmill Walking Speed During Gait Training
Treadmill walking speed will be recorded during supervised gait-training sessions. Speed will be expressed in kilometers per hour (km/h) and adjusted according to each participant's walking ability and tolerance. Changes in treadmill walking speed will be evaluated to characterize progression in training performance across the intervention period.
Measured: During the 20 gait-training sessions over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start3 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized, parallel-group study includes 24 participants (14 with spinal cord injury and 10 with stroke). All participants undergo two sessions of electrophysiological characterization and stimulation optimization before being assigned to either single-electrode or multi-electrode tSCS combined with gait training. The initial allocation procedure used simple randomization. During SCI recruitment, stratified randomization based on baseline walking ability (ambulatory or non-ambulatory) was introduced to improve balance between intervention groups. The SCI sample size was increased to 14 participants. Each participant receives one intervention over 20 gait-training sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Mohamed Bouri, PhD, Study chair, REHAssist - Ecole Polytechnique Fédérale de Lausanne (EPFL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895888
- Sponsor's protocol ID
- University Sao Paulo GH
- Other IDs
- 89779325.4.0000.0068
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37419109Hofstoetter 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.
PubMed 29381748Hofstoetter 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.
PubMed 26450344Calvert 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.
PubMed 31553681Zorkot 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.
PubMed 40644161
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Guided Spatiotemporal Multi-Electrode Versus Single-Electrode Transcutaneous Spinal Cord Stimulation Combined With Gait Training in Individuals With Spinal Cord Injury or Stroke
- ClinicalTrials.gov ID
- NCT07895888
- Acronym / sponsor ID
- University Sao Paulo GH
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Transcutaneous Spinal Cord Stimulation, Multi-Electrode tSCS, Machine Learning, Personalized Neuromodulation, Spatiotemporal tSCS, Gait Rehabilitation, Neurorehabilitation, Muscle Recruitment Selectivity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do electrode positions and stimulation intensities affect selective muscle recruitment, and how do responses vary between participants and days?
- Can ML-based optimization identify stimulation settings with selectivity comparable to complete mapping of muscle responses, using fewer tests and less time?
- Does personalized multi-electrode stimulation, synchronized with specific gait phases, improve walking function more than single-electrode tonic stimulation when both are combined with gait training?
The study includes 24 participants (14 with spinal cord injury and 10 with stroke) and consists of two stages.
Stage 1 - Characterization of tSCS Selectivity and Stimulation Optimization
All participants complete two experimental sessions while lying down. Researchers compare muscle responses to stimulation at a central electrode and at multiple spinal electrode locations. Electrical responses in the leg muscles are recorded using surface electromyography (EMG), and spinal reflexes are assessed using paired electrical pulses.
By systematically testing electrode positions and stimulation intensities, researchers build a map of which leg muscles respond to each setting (stimulation landscape). They assess the selective recruitment of different muscle groups, compare stimulation locations, and examine differences between participants and across the two sessions. They also test whether ML-based optimization can find similarly selective settings more efficiently than the complete mapping procedure.
Stage 2 - tSCS Combined With Gait Training
Participants are randomly assigned to one of two groups: single-electrode or multi-electrode tSCS, both combined with gait training. During spinal cord injury recruitment, the randomization procedure was adapted to better balance participants with different baseline walking abilities across groups.
Before each training session, participants lie down for an individualized calibration. An ML-based optimization method uses recorded muscle responses to select electrode positions and stimulation intensities for the subsequent walking session.
During walking, the single-electrode group receives continuous stimulation through one selected electrode. In the multi-electrode group, stimulation is delivered through electrodes selected to preferentially recruit different target muscle groups. A predefined walking-cycle model determines when stimulation should be delivered, based on gait phases detected in real time by wearable movement sensors.
Both groups complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session. Walking speed is selected according to each participant's comfort and ability, with therapist adjustments, body-weight support, and physical assistance as needed.
Clinical and functional assessments are conducted before the intervention (T0), after the 20 sessions (T1), and at a 30-day follow-up (T2). They examine walking performance, muscle strength, spasticity, balance, and mobility. Additional measurements assess muscle activation, brain activity, and biological markers associated with neuroplasticity. The follow-up assesses whether changes are maintained after training.
Detailed description
Background and Rationale
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation approach that modulates spinal sensorimotor circuits through the recruitment of afferent fibers. When combined with rehabilitation, tSCS may facilitate voluntary motor control and functional recovery in individuals with spinal cord injury (SCI) or stroke.
Conventional tSCS commonly applies tonic stimulation through a single electrode, which may limit the ability to preferentially recruit specific lower-limb muscle groups. This study investigates a personalized multi-electrode approach combining machine-learning (ML)-based optimization of stimulation settings with a predefined feedforward strategy that coordinates stimulation with the walking cycle. Stimulation configurations are selected according to individual muscle responses during calibration and then activated according to gait phases detected during walking.
The study has three objectives: (1) to assess the selectivity of tSCS and characterize the spatial distribution and between-participant and between-session variability of muscle recruitment; (2) to assess whether ML-based optimization identifies selective stimulation configurations more efficiently than systematic mapping of muscle responses; and (3) to compare changes in walking function following multi-electrode versus single-electrode tonic tSCS, both combined with gait training.
Study Design
This is a prospective, controlled, randomized, parallel-group interventional study involving 24 participants, including 14 with SCI and 10 with stroke. The protocol includes two sequential stages: electrophysiological characterization and stimulation optimization, followed by a gait-training intervention.
All participants undergo the first stage. For the second stage, participants are assigned to one of two intervention groups: single-electrode or multi-electrode tSCS, both combined with gait training.
The initial allocation procedure used simple randomization. During SCI recruitment, stratified randomization based on baseline walking ability (ambulatory or non-ambulatory) was introduced to improve balance between the intervention groups. The SCI sample size was increased to 14 participants. Each participant receives only one of the two interventions throughout the training program.
Stage 1 - Characterization of tSCS Selectivity and ML-Based Optimization
All participants complete two sessions in a supine position to examine muscle recruitment selectivity and the reproducibility of responses across days.
Stimulation is tested using a central spinal electrode and multiple electrode locations over the thoracolumbar region. Posterior root-muscle (PRM) reflexes are assessed with paired-pulse stimulation, and evoked responses are recorded bilaterally by surface electromyography (EMG).
Systematic testing of electrode positions and stimulation intensities is used to construct individual stimulation landscapes. These maps describe the distribution of evoked lower-limb muscle responses across stimulation settings, with particular attention to four target groups: left proximal, right proximal, left distal, and right distal muscles. They are used to compare recruitment selectivity between stimulation configurations and to examine variability between participants and between the two sessions.
An ML-based optimization method is evaluated for identifying settings that preferentially recruit target muscle groups. Its results are compared with the comprehensive stimulation landscapes, focusing on achieved selectivity, the number of stimulation tests needed, and the time required to identify suitable configurations.
Stage 2 - tSCS Combined With Gait Training
Participants complete 20 supervised gait-training sessions over four weeks (five sessions per week). Each session includes a supine calibration procedure before gait training. Muscle responses recorded during electrical stimulation are used by the ML-based method to select individualized electrode positions and stimulation intensities. This repeated calibration allows settings to be adapted to day-to-day differences in responses.
Single-Electrode tSCS
For the single-electrode intervention, calibration identifies a stimulation electrode and intensity intended to recruit lower-limb muscles broadly. During gait training, continuous tonic stimulation is delivered through the selected electrode.
Multi-Electrode tSCS
For the multi-electrode intervention, calibration identifies configurations that preferentially recruit different target muscle groups. A predefined feedforward gait model specifies when each configuration should be activated during the walking cycle. Wearable inertial measurement units (IMUs) detect gait phases in real time, and the stimulation system uses this information to deliver the previously selected stimulation patterns at the corresponding phases. Optimization of stimulation settings is performed before, rather than during, walking.
Gait Training Procedure
Both groups receive 30 minutes of treadmill-based gait training per session with a body-weight support system. Participants walk at a comfortable, self-selected speed, with therapist adjustments when necessary. Body-weight support and additional physical assistance are adapted to each participant's functional abilities and safety needs.
Clinical, Biomechanical, and Neurophysiological Assessments
Clinical and functional evaluations take place before the intervention (T0), after completion of the 20 training sessions (T1), and at a 30-day follow-up (T2). The main intervention comparisons focus on changes from T0 to T1; T2 is used to examine the maintenance of changes after training.
Functional assessments cover walking performance and independence, mobility, balance, lower-limb strength, and spasticity. Measures include the 10-Meter Walk Test (10MWT), Timed Up and Go (TUG), Berg Balance Scale, Medical Research Council muscle strength scale, and Modified Ashworth Scale, together with population-specific assessments such as the Walking Index for Spinal Cord Injury II (WISCI II) and the Fugl-Meyer Assessment of the Lower Extremity. Assessments are performed according to each participant's functional abilities.
Surface EMG and wearable sensors assess muscle activity and gait characteristics. Three-dimensional motion capture is used when feasible according to the participant's walking ability. Additional investigations include electroencephalography (EEG) for cortical activity, functional near-infrared spectroscopy (fNIRS) for cortical hemodynamic responses, and blood-based analyses of brain-derived neurotrophic factor (BDNF) and genetic variants related to neuroplasticity. The timing of these measurements follows the schedule for each assessment modality.
The study aims to provide evidence on muscle recruitment selectivity, the efficiency of ML-guided calibration, and the functional and physiological effects of personalized multi-electrode tSCS for gait rehabilitation in SCI and stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective, randomized, parallel-group study includes 24 participants (14 with spinal cord injury and 10 with stroke). All participants undergo two sessions of electrophysiological characterization and stimulation optimization before being assigned to either single-electrode or multi-electrode tSCS combined with gait training. The initial allocation procedure used simple randomization. During SCI recruitment, stratified randomization based on baseline walking ability (ambulatory or non-ambulatory) was introduced to improve balance between intervention groups. The SCI sample size was increased to 14 participants. Each participant receives one intervention over 20 gait-training sessions.
| Arm | Type | Receives |
|---|---|---|
| Single-Electrode tSCS + Gait Training | Active comparator | Device: Single-Electrode Tonic tSCSParticipants 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. |
| Multi-Electrode tSCS + Gait Training | Experimental | Device: Multi-Electrode Spatiotemporal tSCSParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged 18 to 65 years.
- Individuals with walking impairment associated with spinal cord injury (SCI) or stroke, including ambulatory and non-ambulatory participants.
- Provision of written informed consent.
- Traumatic spinal cord injury.
- SCI diagnosis at least 3 months before enrollment.
Key exclusion criteria (14 listed)
- Cognitive impairment interfering with the ability to understand and follow simple instructions.
- Neurodegenerative diseases.
- Severe cardiovascular conditions that contraindicate physical exercise.
- Osteoporotic fractures or severe osteoporosis associated with a high risk of fracture.
- Body weight exceeding 120 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Electrode Tonic tSCSAlso: tSCSNon-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. | Device | Single-Electrode tSCS + Gait Training |
| Multi-Electrode Spatiotemporal tSCSAlso: spatio-temporal tSCSParticipants 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. | Device | Multi-Electrode tSCS + Gait Training |
Primary outcome
Change in Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Time frame: Baseline (T0) and after 4 weeks of intervention (T1)
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.
17 secondary outcomes
Change in Walking Ability Assessed by the Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Balance Assessed by the Berg Balance Scale (BBS)
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Functional Mobility Assessed by the Timed Up and Go Test (TUG)
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Walking Speed at 30-Day Follow-Up Assessed by the 10MWT
Time frame: Baseline (T0) and 30-day follow-up after completion of the intervention (T2)
Gait-Phase-Dependent Muscle Activation Assessed by the Phase Selectivity Index (PSI)
Time frame: During the first and twentieth gait-training sessions (approximately 4 weeks apart)
Change in Spatial Gait Parameters Assessed by Instrumented Gait Analysis
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Walking Speed Assessed by Instrumented Gait Analysis
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Gait Cadence Assessed by Instrumented Gait Analysis
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Temporal Gait Phase Parameters Assessed by Instrumented Gait Analysis
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Resting-State EEG Spectral Power
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Cortical Hemodynamic Response Assessed by fNIRS
Time frame: During the first and twentieth gait-training sessions (approximately 4 weeks apart)
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2)
Change in Body-Weight Support During Treadmill Gait Training
Time frame: During the 20 gait-training sessions over 4 weeks
Change in Treadmill Walking Speed During Gait Training
Time frame: During the 20 gait-training sessions over 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 37419109Bryson 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.
- Background: PubMed 29381748Hofstoetter 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.
- Background: PubMed 26450344Hofstoetter 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.
- Background: PubMed 31553681Calvert 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.
- Background: PubMed 40644161Zorkot 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Bouri, PhD study chair
REHAssist - Ecole Polytechnique Fédérale de Lausanne (EPFL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Electrode Tonic tSCS and Multi-Electrode Spatiotemporal tSCS in people with Spinal Cord Injuries (SCI), run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Speed Assessed by the 10-Meter Walk Test (10MWT) (time frame: Baseline (T0) and after 4 weeks of intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07895888, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.