Combined rTMS and tSCS for Upper Limb Recovery in Cervical SCI
2026年5月8日 更新者：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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Gobinathan Chandran, MBBS
- 电话号码：+65 94575924
- 邮箱：Gobinathan_CHANDRAN@nuhs.edu.sg
研究联系人备份
- 姓名：Tang Ning, PhD
- 邮箱：ning_tang@nuhs.edu.sg
学习地点
-
-
-
Singapore、新加坡
- Alexandra Hospital/ National University Hospital
-
接触：
- Gobinathan Chandran
- 电话号码：+65 94575924
- 邮箱：gobinathan_chandran@nuhs.edu.sg
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
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.
|
|
有源比较器：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. |
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Upper Extremity Motor Score (UEMS)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：Week 0
|
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
|
Week 0
|
|
Grip/Pinch Strength
大体时间：Week 12
|
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
|
Week 12
|
|
Grip/Pinch Strength
大体时间：Week 16
|
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
|
Week 16
|
|
Grip/Pinch Strength
大体时间：Week 24
|
Maximal grip force (Jamar dynamometer), lateral pinch, tip pinch, and tripod pinch (pinch gauge)
|
Week 24
|
|
Nine-Hole Peg Test
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Week 0
|
Gross manual dexterity (number of blocks transferred in 60 seconds)
|
Week 0
|
|
Box and Block Test
大体时间：Week 12
|
Gross manual dexterity (number of blocks transferred in 60 seconds)
|
Week 12
|
|
Box and Block Test
大体时间：Week 16
|
Gross manual dexterity (number of blocks transferred in 60 seconds)
|
Week 16
|
|
Box and Block Test
大体时间：Week 24
|
Gross manual dexterity (number of blocks transferred in 60 seconds)
|
Week 24
|
|
Capabilities of Upper Extremity Test (CUE-T)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：Week 24
|
Patient-identified goals scored on a standardized attainment scale.
Generally, a higher score indicates a better outcome.
|
Week 24
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gobinathan Chandran, MBBS、NUH
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年3月30日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2028年12月30日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 1833493
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
According to institution research polices, research agreement needs to be signed before sharing individual data with external parties.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.