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Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI

12. maj 2026 opdateret af: National University Hospital, Singapore

A Randomized Controlled Trial Comparing Combined TMS-tSCS Neuromodulation Versus tSCS Alone Lower Limb Rehabilitation in Chronic Incomplete SCI

he goal of this clinical trial is to learn if combined brain and spinal cord stimulation using TMS-tSCS can improve leg strength and walking recovery in adults with chronic incomplete spinal cord injury.

The main questions it aims to answer are:

Does combined TMS-tSCS improve lower limb motor function more than tSCS alone? Is combined TMS-tSCS safe and does it improve walking speed, independence, muscle activity, spasticity, and nerve pathway function?

Researchers will compare combined TMS-tSCS with tSCS alone with sham TMS to see if adding brain stimulation leads to better recovery than spinal stimulation alone.

Participants will:

Attend 32 treatment sessions over 16 weeks. Receive either combined TMS-tSCS or tSCS with sham TMS. Undergo assessments of leg strength, walking speed, daily function, muscle stiffness, muscle activity, and nerve pathway function before and after treatment.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background: Spinal cord injury (SCI) affects 15.4 million people worldwide, with 30-40% of incomplete SCI patients remaining nonambulatory, highlighting the importance of gait recovery in rehabilitation. While transcutaneous spinal cord stimulation (tSCS) has emerged as a promising non-invasive neuromodulation technique for enhancing motor recovery, the therapeutic potential of combining tSCS with transcranial magnetic stimulation (TMS) remains largely unexplored. This combination may leverage the complementary mechanisms of supraspinal and spinal neuromodulation to enhance corticospinal tract plasticity and functional motor outcomes. Objective: To evaluate the efficacy and safety of combined TMS-tSCS intervention compared to tSCS alone for improving lower extremity motor function in individuals with chronic incomplete spinal cord injury. Methods: This prospective, randomized, controlled, assessor-blinded clinical trial will enroll 60 participants with chronic (>12 months post-injury) incomplete spinal cord injury (AIS C or D) aged 18-65 years from Alexandra Hospital, Singapore. Participants will be randomized 1:1 to receive either combined TMS-tSCS (intervention group) or tSCS with sham TMS (control group) for 16 weeks (32 sessions). The primary outcome is change in Lower Extremity Motor Score (LEMS) from baseline to 16 weeks. Secondary outcomes include walking speed (10-Meter Walk Test), functional independence (Spinal Cord Independence Measure-III), spasticity (Modified Ashworth Scale), electromyography of the lower limb muscles and neurophysiological measures of corticospinal excitability. Expected Outcomes: We hypothesize that combined TMS-tSCS will yield superior improvements in LEMS (≥2 points greater improvement) compared to tSCS alone, with enhanced corticospinal tract plasticity as evidenced by neurophysiological measures.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  • Age 18-65 years at enrolment
  • Chronic traumatic spinal cord injury, defined as ≥12 months post-injury
  • Incomplete spinal cord injury, AIS grade C or D
  • Neurological level of injury from C2 to L1
  • Baseline Lower Extremity Motor Score (LEMS) >10 points
  • Medically stable
  • Able to provide informed consent
  • Able to commit to the full study duration
  • Able to attempt the 10-Meter Walk Test and 6-Minute Walk Test, with or - without assistive devices and standby assistance

Exclusion Criteria

  • History of seizures or epilepsy
  • Implanted electronic devices, such as: Pacemaker, Cochlear implant, Deep brain stimulator, Spinal cord stimulator, Metallic implants in the head or spine
  • Pregnancy or planned pregnancy
  • Active psychiatric disorder or cognitive impairment
  • Concomitant neurological conditions, such as: Stroke, Traumatic brain injury and Neuropathy
  • Skin breakdown at electrode sites
  • Current participation in another clinical trial
  • History of skull surgery or craniotomy
  • Use of medications that alter cortical excitability within the past 2 weeks

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: iTBS combined with tSCS plus standardized lower limb rehabilitation
Interventions are delivered twice weekly for 16 weeks (32 sessions): iTBS over M1 followed by combined tSCS plus lower limb rehabilitation (45-60 min). tSCS uses a constant-current stimulator with 5×10 cm electrodes at placed at one level above and below the site of the spinal cord injury, with reference electrodes over the ASIS or clavicles. Parameters: biphasic pulses at 30 Hz, 1 ms pulses with 10 kHz carrier frequency, intensity 40-120 mA, delivered continuously for ~45 minutes.The iTBS protocol consists of bursts of 3 pulses at 50 Hz, repeated at 5 Hz (200 ms between bursts), delivered in 2-second trains with 8-second inter-train intervals. Each session will deliver 600 pulses total. The stimulation target will be the leg motor area of the primary motor cortex, identified using established anatomical landmarks and confirmed by eliciting motor evoked potentials (MEPs) in lower extremity muscles. Lower limb rehabilitation follows immediately, supervised by a physiotherapist.
Enhed: Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that enhances cortical excitability and corticospinal drive. Intermittent theta burst stimulation (iTBS), a brief patterned form of rTMS, produces lasting facilitatory effects and is more time-efficient. Evidence indicates rTMS improves motor function, reduces spasticity, and enhances neuroplasticity in SCI.
Enhed: Transcutaneous Spinal Cord Stimulation
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that delivers electrical stimulation over the spine to activate sensory afferents and enhance spinal motor circuit excitability. Early studies showed it can enable voluntary movement even in motor-complete spinal cord injury (SCI), with subsequent research demonstrating improvements in motor function, standing, and walking in incomplete SCI. Evidence suggests tSCS modulates both spinal and corticospinal pathways, supporting neuroplasticity. The Up-LIFT trial (2024) provided strong clinical evidence, showing that tSCS combined with rehabilitation significantly improved upper limb strength and function in chronic cervical SCI, with 72% of participants meeting effectiveness endpoints and no serious adverse events. Later studies confirmed its safety in home and community settings, though standardization and larger trials remain needed.
Aktiv komparator: tSCS plus standardized lower limb rehabilitation only
tSCS uses a constant-current stimulator with 5×10 cm electrodes at placed at one level above and below the site of the spinal cord injury, with reference electrodes over the ASIS or clavicles. Parameters: biphasic pulses at 30 Hz, 1 ms pulses with 10 kHz carrier frequency, intensity 40-120 mA, delivered continuously for ~45 minutes. Lower limb rehabilitation follows immediately, supervised by a physiotherapist.
Enhed: Transcutaneous Spinal Cord Stimulation
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that delivers electrical stimulation over the spine to activate sensory afferents and enhance spinal motor circuit excitability. Early studies showed it can enable voluntary movement even in motor-complete spinal cord injury (SCI), with subsequent research demonstrating improvements in motor function, standing, and walking in incomplete SCI. Evidence suggests tSCS modulates both spinal and corticospinal pathways, supporting neuroplasticity. The Up-LIFT trial (2024) provided strong clinical evidence, showing that tSCS combined with rehabilitation significantly improved upper limb strength and function in chronic cervical SCI, with 72% of participants meeting effectiveness endpoints and no serious adverse events. Later studies confirmed its safety in home and community settings, though standardization and larger trials remain needed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lower Extremity Motor Score (LEMS)
Tidsramme: Week 0
Description: The LEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), representing the summed strength of five key muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, great toe extensors, and ankle plantarflexors), graded on a 0-5 scale for each muscle group. The total LEMS ranges from 0 to 50 points, with higher scores indicating greater motor strength
Week 0
Lower Extremity Motor Score (LEMS)
Tidsramme: Week 8
The LEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), representing the summed strength of five key muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, great toe extensors, and ankle plantarflexors), graded on a 0-5 scale for each muscle group. The total LEMS ranges from 0 to 50 points, with higher scores indicating greater motor strength
Week 8
Lower Extremity Motor Score (LEMS)
Tidsramme: Week 16
Description: The LEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), representing the summed strength of five key muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, great toe extensors, and ankle plantarflexors), graded on a 0-5 scale for each muscle group. The total LEMS ranges from 0 to 50 points, with higher scores indicating greater motor strength
Week 16
Lower Extremity Motor Score (LEMS)
Tidsramme: Week 20
Description: The LEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), representing the summed strength of five key muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, great toe extensors, and ankle plantarflexors), graded on a 0-5 scale for each muscle group. The total LEMS ranges from 0 to 50 points, with higher scores indicating greater motor strength
Week 20

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10-Meter Walk Test (10MWT)
Tidsramme: Week 0
Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
Week 0
10-Meter Walk Test (10MWT)
Tidsramme: Week 8
Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
Week 8
10-Meter Walk Test (10MWT)
Tidsramme: Week 16
Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
Week 16
6-Minute Walk Test (6MWT)
Tidsramme: Week 0
6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
Week 0
6-Minute Walk Test (6MWT)
Tidsramme: Week 8
6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
Week 8
6-Minute Walk Test (6MWT)
Tidsramme: Week 16
6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
Week 16
6-Minute Walk Test (6MWT)
Tidsramme: Week 20
6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
Week 20
Spinal Cord Independence Measure-III (SCIM-III)
Tidsramme: Week 0
Spinal Cord Independence Measure-III (SCIM-III) is a disability scale specifically developed for persons with SCI, assessing self-care (0- 20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The total score ranges from 0-100, with higher scores indicating greater independence
Week 0
Spinal Cord Independence Measure-III (SCIM-III)
Tidsramme: Week 8
Spinal Cord Independence Measure-III (SCIM-III) is a disability scale specifically developed for persons with SCI, assessing self-care (0- 20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The total score ranges from 0-100, with higher scores indicating greater independence
Week 8
Spinal Cord Independence Measure-III (SCIM-III)
Tidsramme: Week 16
Spinal Cord Independence Measure-III (SCIM-III) is a disability scale specifically developed for persons with SCI, assessing self-care (0- 20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The total score ranges from 0-100, with higher scores indicating greater independence
Week 16
Spinal Cord Independence Measure-III (SCIM-III)
Tidsramme: Week 20
Spinal Cord Independence Measure-III (SCIM-III) is a disability scale specifically developed for persons with SCI, assessing self-care (0- 20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The total score ranges from 0-100, with higher scores indicating greater independence
Week 20
Modified Ashworth Scale (MAS)
Tidsramme: Week 0
Modified Ashworth Scale (MAS) will be used to assess spasticity in bilateral hip flexors, knee extensors, and ankle plantarflexors, graded from 0 (no increase in tone) to 4 (limb rigid in flexion or extension).
Week 0
Modified Ashworth Scale (MAS)
Tidsramme: Week 8
Modified Ashworth Scale (MAS) will be used to assess spasticity in bilateral hip flexors, knee extensors, and ankle plantarflexors, graded from 0 (no increase in tone) to 4 (limb rigid in flexion or extension).
Week 8
Modified Ashworth Scale (MAS)
Tidsramme: Week 16
Modified Ashworth Scale (MAS) will be used to assess spasticity in bilateral hip flexors, knee extensors, and ankle plantarflexors, graded from 0 (no increase in tone) to 4 (limb rigid in flexion or extension).
Week 16
Modified Ashworth Scale (MAS)
Tidsramme: Week 20
Modified Ashworth Scale (MAS) will be used to assess spasticity in bilateral hip flexors, knee extensors, and ankle plantarflexors, graded from 0 (no increase in tone) to 4 (limb rigid in flexion or extension).
Week 20
10-Meter Walk Test (10MWT)
Tidsramme: Week 20
Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
Week 20
Peak-to-peak amplitude of motor evoked potential (MEP)
Tidsramme: Week 0
Measured by transcranial magnetic stimulation (TMS). Amplitude, latency, resting and active motor thresholds from FDI and APB will be recorded. The bigger value of peak-to peak amplitude of MEP indicates better outcome
Week 0
Peak-to-peak amplitude of motor evoked potential (MEP)
Tidsramme: Week 8
Measured by transcranial magnetic stimulation (TMS). Amplitude, latency, resting and active motor thresholds from FDI and APB will be recorded. The bigger value of peak-to peak amplitude of MEP indicates better outcome
Week 8
Peak-to-peak amplitude of motor evoked potential (MEP)
Tidsramme: Week 16
Measured by transcranial magnetic stimulation (TMS). Amplitude, latency, resting and active motor thresholds from FDI and APB will be recorded. The bigger value of peak-to peak amplitude of MEP indicates better outcome
Week 16
Peak-to-peak amplitude of motor evoked potential (MEP)
Tidsramme: Week 20
Measured by transcranial magnetic stimulation (TMS). Amplitude, latency, resting and active motor thresholds from FDI and APB will be recorded. The bigger value of peak-to peak amplitude of MEP indicates better outcome
Week 20
Root-Mean-Square (RMS) of Electromyography (EMG)
Tidsramme: Week 0
Surface electromyography (EMG) will be recorded bilaterally from the tibialis anterior, medial gastrocnemius, rectus femoris, and biceps femoris muscles. EMG signals will be recorded during resting state for 10s and isometric muscle contraction for 5s. Normalized EMG RMS will be calculated accordingly. Higher normalized EMG RMS during isometric muscle contraction indicates more muscle engagement.
Week 0
Root-Mean-Square (RMS) of Electromyography (EMG)
Tidsramme: Week 8
Surface electromyography (EMG) will be recorded bilaterally from the tibialis anterior, medial gastrocnemius, rectus femoris, and biceps femoris muscles. EMG signals will be recorded during resting state for 10s and isometric muscle contraction for 5s. Normalized EMG RMS will be calculated accordingly. Higher normalized EMG RMS during isometric muscle contraction indicates more muscle engagement.
Week 8
Root-Mean-Square (RMS) of Electromyography (EMG)
Tidsramme: Week 16
Surface electromyography (EMG) will be recorded bilaterally from the tibialis anterior, medial gastrocnemius, rectus femoris, and biceps femoris muscles. EMG signals will be recorded during resting state for 10s and isometric muscle contraction for 5s. Normalized EMG RMS will be calculated accordingly. Higher normalized EMG RMS during isometric muscle contraction indicates more muscle engagement.
Week 16
Root-Mean-Square (RMS) of Electromyography (EMG)
Tidsramme: Week 20
Surface electromyography (EMG) will be recorded bilaterally from the tibialis anterior, medial gastrocnemius, rectus femoris, and biceps femoris muscles. EMG signals will be recorded during resting state for 10s and isometric muscle contraction for 5s. Normalized EMG RMS will be calculated accordingly. Higher normalized EMG RMS during isometric muscle contraction indicates more muscle engagement.
Week 20

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National University Hospital, Singapore

Efterforskere

  • Ledende efterforsker: Gobinathan Chandran, MBBS, NUH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

30. december 2027

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1773917

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

According to institution research polices, research agreement needs to be signed before sharing individual data with external parties.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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