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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	20 Hz rTMS (Brain)	Higher frequency (\>5 Hz) trains increase cortical excitability.
DEVICE	iTBS rTMS (Brain)	Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
DEVICE	Anode tsDCS (Spinal)	Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
DEVICE	20 Hz current square-wave pulses (Spinal)	Higher frequency (\>5 Hz) of current increase cortical excitability.
DEVICE	iTBS (Spinal)	Intermittent theta-burst stimulation (iTBS) is a newer approach. it may increase corticospinal excitability.
DEVICE	sham	with sham stimulation on brain and spinal.

Timeline

• Start date: 2019-12-09
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2019-12-11
• Last updated: 2023-01-31

Locations

1 site across 1 country: Taiwan