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Combined rTMS and tSCS for Upper Limb Recovery in Cervical SCI

8 de maio de 2026 atualizado por: National University Hospital, Singapore

Combined Repetitive Transcranial Magnetic Stimulation and Transcutaneous Spinal Cord Stimulation for Upper Limb Recovery in Chronic Incomplete Cervical Spinal Cord Injury: Pilot Randomized Controlled Trial

This clinical trial investigates whether combining cortical and spinal neuromodulation can improve upper limb motor recovery in adults with chronic incomplete cervical spinal cord injury (SCI). Restoring upper limb function is the top rehabilitation priority for individuals with tetraplegia, yet effective interventions remain limited.

The study combines transcutaneous spinal cord stimulation (tSCS), which enhances spinal circuit excitability, with intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation that increases cortical excitability and strengthens descending motor pathways. While each approach has shown independent promise, their combined use has not been evaluated in a controlled trial.

Eligible participants are adults aged 21-65 with chronic (>12 months post-injury) incomplete cervical SCI (ASIA Impairment Scale grade C or D, levels C2-C8). A total of 24 participants will be randomised 1:1 to either combined iTBS and tSCS plus standardised upper limb rehabilitation, or tSCS plus rehabilitation alone, across 24 sessions over 12 weeks.

The primary outcome is change in Upper Extremity Motor Score from baseline to week 12. Secondary outcomes cover functional performance, independence, spasticity, corticospinal excitability, quality of life, and goal attainment. Assessments occur at baseline, post-intervention, and at 4- and 12-week follow-up.

As a pilot randomised controlled trial, this study will generate the first controlled evidence on adjunctive cortical neuromodulation alongside tSCS-based rehabilitation, while also producing feasibility data to inform the design of a future definitive multicentre trial.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Background: Cervical spinal cord injury (SCI) results in severe upper limb impairment, with restoration of hand and arm function ranked as the highest rehabilitation priority by individuals with tetraplegia. Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising approach for enhancing upper limb recovery. Intermittent theta burst stimulation (iTBS), an efficient form of repetitive transcranial magnetic stimulation, can enhance cortical excitability and descending motor drive. However, the benefit of combining these complementary neuromodulation modalities to simultaneously target supraspinal and spinal circuits has not been evaluated in a controlled trial.

Objective: This study aims to evaluate the feasibility, safety, and preliminary efficacy of combined cortical neuromodulation (iTBS) and spinal neuromodulation (tSCS) versus tSCS alone, each paired with standardized upper limb rehabilitation, for improving upper limb motor function in chronic incomplete cervical SCI.

Methods: This single-center, two-arm, assessor-blinded, pilot randomized controlled trial will enroll 24 adults aged 21 to 65 years with chronic (more than 12 months post-injury) incomplete cervical SCI (American Spinal Injury Association Impairment Scale grade C or D, neurological level C2 to C8). Participants will be randomized 1:1 to receive either iTBS combined with tSCS plus standardized upper limb rehabilitation or tSCS plus upper limb rehabilitation alone. Interventions will be delivered twice weekly for 12 weeks (24 sessions). The primary outcome is the change in Upper Extremity Motor Score from baseline to 12 weeks. Secondary outcomes include measures of upper limb function, independence, spasticity, corticospinal excitability, quality of life, and goal attainment. Assessments will be conducted at baseline, post-intervention, and at 4-week and 12-week follow-up.

Conclusions: This pilot trial will provide the first controlled evidence on whether adjunctive cortical neuromodulation via iTBS produces additional upper limb motor recovery beyond tSCS-based rehabilitation in chronic incomplete cervical SCI. Feasibility data and effect size estimates will inform the design of a subsequent multicenter confirmatory trial.

Tipo de estudo

Intervencional

Inscrição (Estimado)

24

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Chronicity: More than 12 months post-injury at enrollment
  • Injury type: Traumatic or non-traumatic incomplete cervical SCI, neurological level C2 to C8
  • AIS classification: Grade C or D
  • UEMS: 10 to 20 out of 25 on the more impaired side; lower bound 10 ensures sufficient voluntary activation for task training and elicitable MEPs, upper bound avoids ceiling effects.
  • Grip strength: MMT grade 3 or higher in finger flexors (C8 myotome) on at least one side.
  • Hand function: Able to transfer at least 1 block across the partition within 60 seconds on the more impaired side.
  • Sitting tolerance: Able to tolerate upright seated posture in own wheelchair for at least 1 continuous hour without symptomatic orthostatic hypotension or pressure-related discomfort requiring position change.
  • Medical stability: No acute medical complications
  • Informed consent: Able to provide written informed consent and comply with the study schedule
  • Medications: Stable regimen for 4 weeks prior, AND participant plus clinician agreement that dosage (baclofen, tizanidine, botulinum toxin) remains unchanged throughout the 12-week intervention; any change logged as protocol deviation
  • Surgical clearance: Cleared by neurosurgeon or orthopedic surgeon for participation in tSCS-based rehabilitation

Exclusion Criteria:

  • Seizure history: History of seizures or epilepsy
  • Implanted devices: Intracranial metallic implants, cochlear implants, cardiac pacemakers, or other implanted electronic devices. Cervical spinal instrumentation (e.g., posterior rods, plates, or screws at C2 to T1) is not an exclusion for tSCS provided overlying skin is intact; participants with hardware directly beneath planned electrode sites will undergo low-intensity test stimulation during screening, and electrode placement will be shifted by one interspace if current distortion, focal discomfort, or unexpected motor thresholds are observed. Intracranial hardware remains an absolute exclusion for iTBS.
  • Prior craniotomy: Prior neurosurgical procedure involving craniotomy
  • Pregnancy: Currently pregnant or intending to become pregnant during the study period
  • Psychiatric or cognitive: Active psychiatric illness (eg, untreated major depression, psychosis) or cognitive impairment precluding informed consent
  • Concurrent neurological disease: Progressive or degenerative neurological condition (eg, multiple sclerosis, motor neuron disease)
  • Concurrent trials: Participation in another interventional rehabilitation or neurostimulation trial
  • Skin integrity: Skin lesions or breakdown at electrode placement sites (scalp or posterior cervical spine)
  • Cortical excitability medications: Medications known to alter cortical excitability (eg, antiepileptic drugs, high-dose benzodiazepines) that cannot be stabilized for at least 2 weeks prior to enrollment
  • Severe spasticity: Modified Tardieu Scale muscle reaction grade 4 (unfatigable clonus >10 s) at elbow or wrist flexors on the more impaired side, or spasticity judged by the treating physician as unresponsive to optimised pharmacological management.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: iTBS combined with tSCS plus standardized upper limb rehabilitation

Interventions are delivered twice weekly for 12 weeks (24 sessions): iTBS over M1 followed by combined tSCS plus upper limb rehabilitation (45-60 min).

tSCS uses a constant-current stimulator with 5×10 cm electrodes at C3-C4 and/or C6-C7, 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.

iTBS is delivered over the M1 hand area contralateral to the more impaired limb. Protocol: 600 pulses (3-pulse bursts at 50 Hz, repeated at 5 Hz, 80% AMT over 3-4 minutes.

Upper limb rehabilitation follows immediately, supervised by a physiotherapist and occupational therapist, based on the Up-LIFT trial protocol. Sessions include reaching, finger movements, pinch, grip, bimanual coordination, and individualised functional tasks, with difficulty progressed systematically.
Dispositivo: 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.
Dispositivo: 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.
Comparador Ativo: tSCS plus standardized upper limb rehabilitation only

Interventions are delivered twice weekly for 12 weeks (24 sessions).

tSCS uses a constant-current stimulator with 5×10 cm electrodes at C3-C4 and/or C6-C7, 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 carrier frequency reduces skin discomfort and enables deeper dorsal root activation.

Upper limb rehabilitation follows immediately, supervised by a physiotherapist and occupational therapist, based on the Up-LIFT trial protocol. Sessions include reaching, finger movements, pinch, grip, bimanual coordination, and individualised functional tasks, with difficulty progressed systematically.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Upper Extremity Motor Score (UEMS)
Prazo: Week 0
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Week 0
Upper Extremity Motor Score (UEMS)
Prazo: Week 12
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Week 12
Upper Extremity Motor Score (UEMS)
Prazo: Week 16
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Week 16
Upper Extremity Motor Score (UEMS)
Prazo: Week 24
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
Prazo: Week 0
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Week 0
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
Prazo: Week 12
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Week 12
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
Prazo: Week 16
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Week 16
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
Prazo: Week 24
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Week 24
Grip/Pinch Strength
Prazo: Week 0
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
Week 0
Grip/Pinch Strength
Prazo: Week 12
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
Week 12
Grip/Pinch Strength
Prazo: Week 16
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
Week 16
Grip/Pinch Strength
Prazo: Week 24
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
Week 24
Nine-Hole Peg Test
Prazo: Week 0
Timed fine motor dexterity assessment. The participant is instructed to pick up the pegs one by one and place them into the holes as fast as possible. Once all pegs are in the holes, the participant immediately removes them one by one and returns them to the container, as fast as possible. The primary score is the number of seconds taken to complete the task. Shorter times indicate better fine manual dexterity.
Week 0
Nine-Hole Peg Test
Prazo: Week 12
Timed fine motor dexterity assessment. The participant is instructed to pick up the pegs one by one and place them into the holes as fast as possible. Once all pegs are in the holes, the participant immediately removes them one by one and returns them to the container, as fast as possible. The primary score is the number of seconds taken to complete the task. Shorter times indicate better fine manual dexterity.t
Week 12
Nine-Hole Peg Test
Prazo: Week 16
Timed fine motor dexterity assessment. The participant is instructed to pick up the pegs one by one and place them into the holes as fast as possible. Once all pegs are in the holes, the participant immediately removes them one by one and returns them to the container, as fast as possible. The primary score is the number of seconds taken to complete the task. Shorter times indicate better fine manual dexterity.
Week 16
Nine-Hole Peg Test
Prazo: Week 24
Timed fine motor dexterity assessment. The participant is instructed to pick up the pegs one by one and place them into the holes as fast as possible. Once all pegs are in the holes, the participant immediately removes them one by one and returns them to the container, as fast as possible. The primary score is the number of seconds taken to complete the task. Shorter times indicate better fine manual dexterity.
Week 24
Box and Block Test
Prazo: Week 0
Gross manual dexterity (number of blocks transferred in 60 seconds)
Week 0
Box and Block Test
Prazo: Week 12
Gross manual dexterity (number of blocks transferred in 60 seconds)
Week 12
Box and Block Test
Prazo: Week 16
Gross manual dexterity (number of blocks transferred in 60 seconds)
Week 16
Box and Block Test
Prazo: Week 24
Gross manual dexterity (number of blocks transferred in 60 seconds)
Week 24
Capabilities of Upper Extremity Test (CUE-T)
Prazo: Week 0
CUE-T is a standardized, performance-based assessment tool designed specifically to measure functional limitations in the arms and hands of individuals with tetraplegia due to SCI. It objectively evaluates how well a person can perform basic and instrumental ADLs, such as reaching, grasping, and manipulating objects. Higher score indicates better outcome.
Week 0
Capabilities of Upper Extremity Test (CUE-T)
Prazo: Week 12
CUE-T is a standardized, performance-based assessment tool designed specifically to measure functional limitations in the arms and hands of individuals with tetraplegia due to SCI. It objectively evaluates how well a person can perform basic and instrumental ADLs, such as reaching, grasping, and manipulating objects. Higher score indicates better outcome.
Week 12
Capabilities of Upper Extremity Test (CUE-T)
Prazo: Week 16
CUE-T is a standardized, performance-based assessment tool designed specifically to measure functional limitations in the arms and hands of individuals with tetraplegia due to SCI. It objectively evaluates how well a person can perform basic and instrumental ADLs, such as reaching, grasping, and manipulating objects. Higher score indicates better outcome.
Week 16
Capabilities of Upper Extremity Test (CUE-T)
Prazo: Week 24
CUE-T is a standardized, performance-based assessment tool designed specifically to measure functional limitations in the arms and hands of individuals with tetraplegia due to SCI. It objectively evaluates how well a person can perform basic and instrumental ADLs, such as reaching, grasping, and manipulating objects. Higher score indicates better outcome.
Week 24
Spinal Cord Independence Measure III (SCIM-III)
Prazo: Week 0
It measures independence in daily activities across three main domains-Self-Care, Respiration/Sphincter Management, and Mobility-with a total score ranging from 0 to 100. Higher score indicates better outcome.
Week 0
Spinal Cord Independence Measure III (SCIM-III)
Prazo: Week 12
It measures independence in daily activities across three main domains-Self-Care, Respiration/Sphincter Management, and Mobility-with a total score ranging from 0 to 100. Higher score indicates better outcome.
Week 12
Spinal Cord Independence Measure III (SCIM-III)
Prazo: Week 16
It measures independence in daily activities across three main domains-Self-Care, Respiration/Sphincter Management, and Mobility-with a total score ranging from 0 to 100. Higher score indicates better outcome.
Week 16
Spinal Cord Independence Measure III (SCIM-III)
Prazo: Week 24
It measures independence in daily activities across three main domains-Self-Care, Respiration/Sphincter Management, and Mobility-with a total score ranging from 0 to 100. Higher score indicates better outcome.
Week 24
R2-R1 in Modified Tardieu Scale
Prazo: Week 0
Modified Tardieu Scale measures velocity-dependent spasticity of elbow and wrist flexors/extensors. R1 (Angle of Catch) is measured during the fast (V3) stretch, indicating when the spastic reflex is triggered. R2 (Full Range of Motion) is measured during the slow (V1) stretch, indicating the maximum joint angle. A lower R2-R1 value is better (indicating less spasticity and more normal muscle behaviour).
Week 0
R2-R1 in Modified Tardieu Scale
Prazo: Week 6
Modified Tardieu Scale measures velocity-dependent spasticity of elbow and wrist flexors/extensors. R1 (Angle of Catch) is measured during the fast (V3) stretch, indicating when the spastic reflex is triggered. R2 (Full Range of Motion) is measured during the slow (V1) stretch, indicating the maximum joint angle. A lower R2-R1 value is better (indicating less spasticity and more normal muscle behaviour).
Week 6
R2-R1 in Modified Tardieu Scale
Prazo: Week 12
Modified Tardieu Scale measures velocity-dependent spasticity of elbow and wrist flexors/extensors. R1 (Angle of Catch) is measured during the fast (V3) stretch, indicating when the spastic reflex is triggered. R2 (Full Range of Motion) is measured during the slow (V1) stretch, indicating the maximum joint angle. A lower R2-R1 value is better (indicating less spasticity and more normal muscle behaviour).
Week 12
R2-R1 in Modified Tardieu Scale
Prazo: Week 16
Modified Tardieu Scale measures velocity-dependent spasticity of elbow and wrist flexors/extensors. R1 (Angle of Catch) is measured during the fast (V3) stretch, indicating when the spastic reflex is triggered. R2 (Full Range of Motion) is measured during the slow (V1) stretch, indicating the maximum joint angle. A lower R2-R1 value is better (indicating less spasticity and more normal muscle behaviour).
Week 16
R2-R1 in Modified Tardieu Scale
Prazo: Week 24
Modified Tardieu Scale measures velocity-dependent spasticity of elbow and wrist flexors/extensors. R1 (Angle of Catch) is measured during the fast (V3) stretch, indicating when the spastic reflex is triggered. R2 (Full Range of Motion) is measured during the slow (V1) stretch, indicating the maximum joint angle. A lower R2-R1 value is better (indicating less spasticity and more normal muscle behaviour).
Week 24
Central Motor Conduction Time (CMCT)
Prazo: Week 0
It evaluates the integrity of the corticospinal tract by subtracting peripheral motor conduction time from the total Motor Evoked Potential (MEP). As per IFCN guidelines: CMCT = MEP latency minus PCT, where PCT = (F-latency + M-latency minus 1) / 2. A shorter CMCT indicates better outcome.
Week 0
Central Motor Conduction Time (CMCT)
Prazo: Week 12
It evaluates the integrity of the corticospinal tract by subtracting peripheral motor conduction time from the total Motor Evoked Potential (MEP). As per IFCN guidelines: CMCT = MEP latency minus PCT, where PCT = (F-latency + M-latency minus 1) / 2. A shorter CMCT indicates better outcome.
Week 12
Central Motor Conduction Time (CMCT)
Prazo: Week 16
It evaluates the integrity of the corticospinal tract by subtracting peripheral motor conduction time from the total Motor Evoked Potential (MEP). As per IFCN guidelines: CMCT = MEP latency minus PCT, where PCT = (F-latency + M-latency minus 1) / 2. A shorter CMCT indicates better outcome.
Week 16
Central Motor Conduction Time (CMCT)
Prazo: Week 24
It evaluates the integrity of the corticospinal tract by subtracting peripheral motor conduction time from the total Motor Evoked Potential (MEP). As per IFCN guidelines: CMCT = MEP latency minus PCT, where PCT = (F-latency + M-latency minus 1) / 2. A shorter CMCT indicates better outcome.
Week 24
peak-to-peak amplitude of motor evoked potential (MEP)
Prazo: 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)
Prazo: Week 12
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 12
peak-to-peak amplitude of motor evoked potential (MEP)
Prazo: 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 outcomes.
Week 16
peak-to-peak amplitude of motor evoked potential (MEP)
Prazo: Week 24
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 24
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Prazo: Week 0
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to5, with higher score indicating worse outcome.
Week 0
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Prazo: Week 12
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to5, with higher score indicating worse outcome.
Week 12
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Prazo: Week 24
The EQ-5D-5L is a standardized, self-reported questionnaire used to measure health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension scores from 1 to5, with higher score indicating worse outcome.
Week 24
Modified goal attainment scale (GAS)
Prazo: Week 0
Patient-identified goals scored on a standardized attainment scale. Generally, a higher score indicates a better outcome.
Week 0
Modified goal attainment scale (GAS)
Prazo: Week 12
Patient-identified goals scored on a standardized attainment scale. Generally, a higher score indicates a better outcome.
Week 12
Modified goal attainment scale (GAS)
Prazo: Week 16
Patient-identified goals scored on a standardized attainment scale. Generally, a higher score indicates a better outcome.
Week 16
Modified goal attainment scale (GAS)
Prazo: Week 24
Patient-identified goals scored on a standardized attainment scale. Generally, a higher score indicates a better outcome.
Week 24

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National University Hospital, Singapore

Investigadores

  • Investigador principal: Gobinathan Chandran, MBBS, NUH

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de março de 2027

Conclusão Primária (Estimado)

30 de junho de 2028

Conclusão do estudo (Estimado)

30 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1833493

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

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