Clinical trial NCT04194099: Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects
Official title: Development and Application of a Novel Neurorehabilitation Technology With Paired Associative Nerve Stimulation in Spinal Cord Injured Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Trans-cranial magnetic stimulation
Trans-spinal direct current stimulation
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Twelve participants will be recruited in this study.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 20 to 65 years incomplete SCI (American Spinal Injury Association Impairment Scale (ASIA) B to D)
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:

1. Having pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
2. Having seizure history
3. Having other neurological, mental, medical problems affect this study

Primary outcomes:
measure: Change of Motor evoked potentials (MEP)
timeFrame: Just before the intervention start and immediately after the intervention finished.
measure: Change of resting motor threshold (RMT)
timeFrame: Just before the intervention start and immediately after the intervention finished.
Secondary outcomes:
measure: Change of Modified Ashworth Scale (MAS)
timeFrame: Just before the intervention start and immediately after the intervention finished.
measure: Change of Lower Extremities Motor Score (LEMS)
timeFrame: Just before the intervention start and immediately after the intervention finished.
measure: Change of functional Magnetic Resonance Imaging (fMRI)
timeFrame: Immediately after the intervention finished.
measure: Change of Surface Electromyography (sEMG)
timeFrame: Just before the intervention start and immediately after the intervention finished.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical university Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chien-Hung Lai, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: