Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects

Taipei Medical University

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: 20 Hz rTMS (Brain); Device: iTBS (Spinal); Device: 20 Hz current square-wave pulses (Spinal); Device: iTBS rTMS (Brain); Device: Anode tsDCS (Spinal); Device: sham

Study type: Interventional

Funder types: Other

Identifiers

NCT04194099

N201905031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 5 patient groups

rTMS (Brain) + tsES (Spinal)

Experimental group

Description:

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

Treatment:

Device: Anode tsDCS (Spinal)

Device: 20 Hz rTMS (Brain)

rTMS (Brain) + tsES (Spinal) or sham stimulation

Experimental group

Description:

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

Treatment:

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

Device: 20 Hz rTMS (Brain)

iTBS rTMS or sham (Brain) + tsES or sham (Spinal)

Experimental group

Description:

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

Treatment:

Device: Anode tsDCS (Spinal)

Device: iTBS rTMS (Brain)

iTBS rTMS or sham (Brain) + iTBS or sham (Spinal)

Experimental group

Description:

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

Treatment:

Device: iTBS rTMS (Brain)

Device: iTBS (Spinal)

sham (no stimulation on brain nor spinal)

Sham Comparator group

Description:

First part Sham stimulation. No second part

Treatment:

Device: sham