AzTrials
AzTrials

Spinal Cord InjuriesNCT04194099

Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects

A study testing 20 Hz rTMS (Brain), iTBS rTMS (Brain) and Anode tsDCS (Spinal) in people with Spinal Cord Injuries, run by Taipei Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) combined with trans-spinal electrical stimulation (tsES) intervention on cortical excitability, brain structure, motor ability of lower limb in individuals with incomplete spinal cord injury. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
20 Hz rTMS (Brain), iTBS rTMS (Brain) and Anode tsDCS (Spinal)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteTaiwan
Study dates
9 Dec 2019to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chien-Hung Lai, MD PhD contact

886-2-27372181 ext. 3538

chlai@tmu.edu.tw

Taiwan1 site, 1 recruiting

  • Taipei Medical university Hospital

    Taipei

    Chien-Hung Lai

    Recruiting

Other trials in Taiwan

About this study

Official title: Development and Application of a Novel Neurorehabilitation Technology With Paired Associative Nerve Stimulation in Spinal Cord Injured Subjects

This study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) combined with trans-spinal electrical stimulation (tsES) intervention on cortical excitability, brain structure, motor ability of lower limb in individuals with incomplete spinal cord injury. Twelve participants will be recruited in this study.

Read the 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.

Being tested
20 Hz rTMS (Brain), iTBS rTMS (Brain), Anode tsDCS (Spinal), 20 Hz current square-wave pulses (Spinal), iTBS (Spinal)
Keywords
Spinal Cord Injuries, Trans-cranial magnetic stimulation, Trans-spinal direct current stimulation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 Hz rTMS (Brain)Device

    Higher frequency (>5 Hz) trains increase cortical excitability.

  • iTBS rTMS (Brain)Device

    Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.

  • Anode tsDCS (Spinal)Device

    Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.

  • 20 Hz current square-wave pulses (Spinal)Device

    Higher frequency (>5 Hz) of current increase cortical excitability.

  • iTBS (Spinal)Device

    Intermittent theta-burst stimulation (iTBS) is a newer approach. it may increase corticospinal excitability.

  • shamDevice

    with sham stimulation on brain and spinal.

Study groups in NCT04194099
Study groupRoleWhat they receive
rTMS (Brain) + tsES (Spinal)ExperimentalFirst part 20 Hz rTMS (Brain) + Anode tsDCS (Spinal) Brain: 1. Train pulse: 2 sec 2. Inter-train: 28 sec 3. Total time: 1200 sec Spinal: Continuous direct current (DC): 1200 sec Second part iTBS rTMS(Brain) + 2.5-mA tsDCS (Spinal) Brain: 1. Train pulse: 2 sec 2. Inter-train: 8 sec 3. Total time: 200 sec Spinal: Continuous direct current (DC): 600 sec
Receives: Device: 20 Hz rTMS (Brain); Device: Anode tsDCS (Spinal)
rTMS (Brain) + tsES (Spinal) or sham stimulationExperimentalFirst part 20 Hz rTMS (Brain) + 20 Hz current square-wave pulses (Spinal) Brain and spinal: 1. Train pulse: 2 sec 2. Inter-train: 28 sec 3. Total time: 1200 sec Second part iTBS rTMS(Brain) + sham 2.5-mA tsDCS (Spinal) Brain: 1. Train pulse: 2 sec 2. Inter-train: 8 sec 3. Total time: 200 sec Spinal: Sham direct current (DC) stimulation
Receives: Device: 20 Hz rTMS (Brain); Device: 20 Hz current square-wave pulses (Spinal)
iTBS rTMS or sham (Brain) + tsES or sham (Spinal)ExperimentalFirst part Brain: 1. Train pulse: 2 sec 2. Inter-train: 8 sec 3. Total time: 200 sec 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
Receives: Device: iTBS rTMS (Brain); Device: Anode tsDCS (Spinal)
iTBS rTMS or sham (Brain) + iTBS or sham (Spinal)ExperimentalFirst part Brain and spinal: 1. Train pulse: 2 sec 2. Inter-train: 8 sec 3. Total time: 200 sec Second part Sham iTBS rTMS (Brain) + Sham 2.5-mA tsDCS (Spinal) Brain: Sham iTBS rTMS Spinal: Sham direct current (DC) stimulation
Receives: Device: iTBS rTMS (Brain); Device: iTBS (Spinal)
sham (no stimulation on brain nor spinal)Sham comparatorFirst part Sham stimulation. No second part
Receives: Device: sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Motor evoked potentials (MEP)

    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.

    Measured: Just before the intervention start and immediately after the intervention finished.

  2. Change of resting motor threshold (RMT)

    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.

    Measured: Just before the intervention start and immediately after the intervention finished.

Secondary outcomes (4)

  1. Change of Modified Ashworth Scale (MAS)

    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

    1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM)
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

    Measured: Just before the intervention start and immediately after the intervention finished.

  2. Change of Lower Extremities Motor Score (LEMS)

    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.

    Measured: Just before the intervention start and immediately after the intervention finished.

  3. Change of functional Magnetic Resonance Imaging (fMRI)

    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.

    Measured: Immediately after the intervention finished.

  4. Change of Surface Electromyography (sEMG)

    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.

    Measured: Just before the intervention start and immediately after the intervention finished.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2019
  2. Study start9 Dec 2019
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04194099
Sponsor's protocol ID
N201905031
Status last verified
Jan 2023
First submitted
5 Dec 2019
Last updated
31 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 20 Hz rTMS (Brain), iTBS rTMS (Brain) and Anode tsDCS (Spinal) in people with Spinal Cord Injuries, run by Taipei Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chien-Hung Lai, MD PhD (886-2-27372181 ext. 3538, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Motor evoked potentials (MEP) (time frame: Just before the intervention start and immediately after the intervention finished.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04194099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in