Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects
NCT ID: NCT04194099
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2019-12-09
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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rTMS (Brain) + tsES (Spinal)
First 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
20 Hz rTMS (Brain)
Higher frequency (\>5 Hz) trains increase cortical excitability.
Anode tsDCS (Spinal)
Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
rTMS (Brain) + tsES (Spinal) or sham stimulation
First 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
20 Hz rTMS (Brain)
Higher frequency (\>5 Hz) trains increase cortical excitability.
20 Hz current square-wave pulses (Spinal)
Higher frequency (\>5 Hz) of current increase cortical excitability.
iTBS rTMS or sham (Brain) + tsES or sham (Spinal)
First 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
iTBS rTMS (Brain)
Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
Anode tsDCS (Spinal)
Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
iTBS rTMS or sham (Brain) + iTBS or sham (Spinal)
First 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
iTBS rTMS (Brain)
Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
iTBS (Spinal)
Intermittent theta-burst stimulation (iTBS) is a newer approach. it may increase corticospinal excitability.
sham (no stimulation on brain nor spinal)
First part Sham stimulation.
No second part
sham
with sham stimulation on brain and spinal.
Interventions
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20 Hz rTMS (Brain)
Higher frequency (\>5 Hz) trains increase cortical excitability.
iTBS rTMS (Brain)
Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
Anode tsDCS (Spinal)
Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
20 Hz current square-wave pulses (Spinal)
Higher frequency (\>5 Hz) of current increase cortical excitability.
iTBS (Spinal)
Intermittent theta-burst stimulation (iTBS) is a newer approach. it may increase corticospinal excitability.
sham
with sham stimulation on brain and spinal.
Eligibility Criteria
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Inclusion Criteria
2. Lesion area above the tenth thoracic vertebra (T10)
3. Injury time more than one year
4. Without range of motion (ROM) limitation
5. Medical condition stable
Exclusion Criteria
2. Having seizure history
3. Having other neurological, mental, medical problems affect this study
20 Years
65 Years
ALL
No
Sponsors
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Taipei Medical University Hospital
OTHER
Responsible Party
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Lai chien hung
Professor
Principal Investigators
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Chien-Hung Lai, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University Hospital
Locations
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Taipei Medical university Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chien-Hung Lai
Role: primary
Other Identifiers
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N201905031
Identifier Type: -
Identifier Source: org_study_id
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