Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI
2026년 5월 12일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
24
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Gobinathan Chandran, MBBS
- 전화번호: +65 94575924
- 이메일: Gobinathan_CHANDRAN@nuhs.edu.sg
연구 연락처 백업
- 이름: Tang Ning, PhD
- 이메일: ning_tang@nuhs.edu.sg
연구 장소
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Singapore, 싱가포르
- Alexandra Hospital/ National University Hospital, Singapore
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연락하다:
- Gobinathan Chandran, MBBS
- 전화번호: +65 94575924
- 이메일: Gobinathan_CHANDRAN@nuhs.edu.sg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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.
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활성 비교기: 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.
|
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Lower Extremity Motor Score (LEMS)
기간: Week 0
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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
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Week 0
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Lower Extremity Motor Score (LEMS)
기간: Week 8
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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
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Week 8
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Lower Extremity Motor Score (LEMS)
기간: Week 16
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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
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Week 16
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Lower Extremity Motor Score (LEMS)
기간: Week 20
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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
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Week 20
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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10-Meter Walk Test (10MWT)
기간: Week 0
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Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
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Week 0
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10-Meter Walk Test (10MWT)
기간: Week 8
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Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
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Week 8
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10-Meter Walk Test (10MWT)
기간: Week 16
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Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
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Week 16
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6-Minute Walk Test (6MWT)
기간: Week 0
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6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
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Week 0
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6-Minute Walk Test (6MWT)
기간: Week 8
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6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
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Week 8
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6-Minute Walk Test (6MWT)
기간: Week 16
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6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
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Week 16
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6-Minute Walk Test (6MWT)
기간: Week 20
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6-Minute Walk Test (6MWT) will measure walking endurance as the total distance walked in 6 minutes on a standardized course.
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Week 20
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Spinal Cord Independence Measure-III (SCIM-III)
기간: Week 0
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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
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Week 0
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Spinal Cord Independence Measure-III (SCIM-III)
기간: Week 8
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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
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Week 8
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Spinal Cord Independence Measure-III (SCIM-III)
기간: Week 16
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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
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Week 16
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Spinal Cord Independence Measure-III (SCIM-III)
기간: Week 20
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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
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Week 20
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Modified Ashworth Scale (MAS)
기간: Week 0
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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).
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Week 0
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Modified Ashworth Scale (MAS)
기간: Week 8
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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).
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Week 8
|
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Modified Ashworth Scale (MAS)
기간: Week 16
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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).
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Week 16
|
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Modified Ashworth Scale (MAS)
기간: Week 20
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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
|
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10-Meter Walk Test (10MWT)
기간: Week 20
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Assess walking speed over a 10-meter distance at both comfortable and maximum speeds, with excellent reliability (ICC > 0.95) established for SCI populations.
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Week 20
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Peak-to-peak amplitude of motor evoked potential (MEP)
기간: Week 0
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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
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Week 0
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Peak-to-peak amplitude of motor evoked potential (MEP)
기간: Week 8
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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
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Week 8
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Peak-to-peak amplitude of motor evoked potential (MEP)
기간: Week 16
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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
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Week 16
|
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Peak-to-peak amplitude of motor evoked potential (MEP)
기간: 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
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Week 20
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Root-Mean-Square (RMS) of Electromyography (EMG)
기간: Week 0
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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.
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Week 0
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Root-Mean-Square (RMS) of Electromyography (EMG)
기간: Week 8
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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.
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Week 8
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Root-Mean-Square (RMS) of Electromyography (EMG)
기간: Week 16
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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.
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Week 16
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Root-Mean-Square (RMS) of Electromyography (EMG)
기간: 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.
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Week 20
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Gobinathan Chandran, MBBS, NUH
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 1일
기본 완료 (추정된)
2027년 12월 30일
연구 완료 (추정된)
2028년 3월 1일
연구 등록 날짜
최초 제출
2026년 5월 12일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1773917
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
According to institution research polices, research agreement needs to be signed before sharing individual data with external parties.
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