- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194099
Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects
Development and Application of a Novel Neurorehabilitation Technology With Paired Associative Nerve Stimulation in Spinal Cord Injured Subjects
Study Overview
Status
Conditions
Detailed Description
Spinal cord injury (SCI) impairs motor and sensory function and affects numerous body functions and daily activities. Insufficient central nervous system plasticity can result in maladaptive changes that prevent full recovery. It's a challenge to guide this plasticity to optimize the functional outcome for individuals with SCI.
Transcranial magnetic stimulation (TMS) and trans-spinal electric stimulation (tsES) may modulate cortical excitability, corticospinal output and spinal circuit. However, few studies investigated the effectiveness of paired nerve stimulation (PNS) on neuroplasticity and functional outcome in persons with SCI. Therefore, this study aim to examine the effects of the combination of these two different non-invasive nerve stimulation with the cycling exercise on the motor cortex and corticospinal circuit excitability as well as functional recovery.
Present study clarifies the effects of five different settings of combined with TMS and tsES intervention and then undergo cycling exercise after PNS on spinal cord and cortical excitability in SCI participants.
It is expected that this project will successfully establish a new neuromodulation technology to enhance cortical, corticospinal and spinal circuit excitability as well as to improve the outcome of lower-limb function and quality of life in persons with SCI. Therefore, this project can not only publish scientific papers, but also can enhance the neuroplasticity and improve function in persons with SCI.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Recruiting
- Taipei Medical University Hospital
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Contact:
- Chien-Hung Lai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20 to 65 years incomplete SCI (American Spinal Injury Association Impairment Scale (ASIA) B to D)
- Lesion area above the tenth thoracic vertebra (T10)
- Injury time more than one year
- Without range of motion (ROM) limitation
- Medical condition stable
Exclusion Criteria:
- Having pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
- Having seizure history
- Having other neurological, mental, medical problems affect this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rTMS (Brain) + tsES (Spinal)
First part 20 Hz rTMS (Brain) + Anode tsDCS (Spinal) Brain:
Spinal: Continuous direct current (DC): 1200 sec Second part iTBS rTMS(Brain) + 2.5-mA tsDCS (Spinal) Brain:
Spinal: Continuous direct current (DC): 600 sec |
Higher frequency (>5 Hz) trains increase cortical excitability.
Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
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Experimental: rTMS (Brain) + tsES (Spinal) or sham stimulation
First part 20 Hz rTMS (Brain) + 20 Hz current square-wave pulses (Spinal) Brain and spinal:
Second part iTBS rTMS(Brain) + sham 2.5-mA tsDCS (Spinal) Brain:
Spinal: Sham direct current (DC) stimulation |
Higher frequency (>5 Hz) trains increase cortical excitability.
Higher frequency (>5 Hz) of current increase cortical excitability.
|
Experimental: iTBS rTMS or sham (Brain) + tsES or sham (Spinal)
First part Brain:
Spinal: Continuous direct current (DC): 190 sec Second part Sham iTBS rTMS (Brain) + 2.5-mA tsDCS (Spinal) Sham iTBS rTMS Brain: Spinal: Continuous direct current (DC): 600 sec |
Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
|
Experimental: iTBS rTMS or sham (Brain) + iTBS or sham (Spinal)
First part Brain and spinal:
Second part Sham iTBS rTMS (Brain) + Sham 2.5-mA tsDCS (Spinal) Brain: Sham iTBS rTMS Spinal: Sham direct current (DC) stimulation |
Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
Intermittent theta-burst stimulation (iTBS) is a newer approach.
it may increase corticospinal excitability.
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Sham Comparator: sham (no stimulation on brain nor spinal)
First part Sham stimulation. No second part |
with sham stimulation on brain and spinal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Motor evoked potentials (MEP)
Time Frame: Just before the intervention start and immediately after the intervention finished.
|
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex.
All TMS is delivered with the participant seated upright on the chair.
Both passive and active conditions, participants are instructed to relax their one hand in the seated position.
TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom).
To locate the optimized site, stimuli are delivered over various points around the Cz (approximate 1 cm distance from Cz).
The optimal site is the location around the Cz that evoked the greatest MEP amplitude in tibialis anterior muscles.
The onset latency and onset to peak amplitude will be assessed.
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Just before the intervention start and immediately after the intervention finished.
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Change of resting motor threshold (RMT)
Time Frame: Just before the intervention start and immediately after the intervention finished.
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Resting motor threshold (RMT) is recorded from tibialis anterior muscles following transcranial magnetic stimulation.
TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom).
To locate the optimal site, stimuli are delivered over various points around the Cz (the distance approximate 1 cm from Cz) to get the hot spot point.
And then measure the RMT using the minimum stimulus intensity that produced a minimal motor evoked response (about 50 micro-volts (µV) in at least 5 of 10 trials) at rest.
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Just before the intervention start and immediately after the intervention finished.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Modified Ashworth Scale (MAS)
Time Frame: Just before the intervention start and immediately after the intervention finished.
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Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows: 0: No increase in muscle tone
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Just before the intervention start and immediately after the intervention finished.
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Change of Lower Extremities Motor Score (LEMS)
Time Frame: Just before the intervention start and immediately after the intervention finished.
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The voluntary muscle strength of five key muscles (hip flexors, knee extensors, ankle dorsiflexors, long toe extensors and ankle plantarflexors) of both lower extremities was tested. Each muscle was given a value between 0 and 5 according to the strength of voluntary muscle contraction. Maximum and minimum LEMS were 50 and 0, respectively. |
Just before the intervention start and immediately after the intervention finished.
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Change of functional Magnetic Resonance Imaging (fMRI)
Time Frame: Immediately after the intervention finished.
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Our study will use 3 Tesla (T) magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging.
Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices, slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 × 192 mm, and vixen size is 3 × 3 × 3 mm.
The EPI scan for 525 seconds.
All subjects are asked to close their eyes and supine.
Our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
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Immediately after the intervention finished.
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Change of Surface Electromyography (sEMG)
Time Frame: Just before the intervention start and immediately after the intervention finished.
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sEMG recordings using pairs of 1 cm-diameter silver/silver chloride recessed sEMG electrodes placed over the muscle bellies 3 cm apart were made from the right and left quadriceps (mainly rectus femoris) and hamstrings. Electrodes were centered on the long axis over muscle bellies for recording during voluntary motor tasks performed by 30 min cycling exercise. The 4 sEMG channels were recorded with a bandwidth of 30 to 500 Hz and a gain of 1,000. Movement sensor and event cue marker outputs were also recorded and, along with the sEMG, were continually digitized at a rate of 2,000 samples/s for the duration of the protocol. |
Just before the intervention start and immediately after the intervention finished.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201905031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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