Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects

NCT04194099 | Unknown

• 1 other identifier: N201905031
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; Trans-cranial magnetic stimulation; Trans-spinal direct current stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (4)

• Change of Modified Ashworth Scale (MAS)

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

• Change of Lower Extremities Motor Score (LEMS)

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

• Change of functional Magnetic Resonance Imaging (fMRI)

  Immediately after the intervention finished.

• Change of Surface Electromyography (sEMG)

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

Study Arms (5)

rTMS (Brain) + tsES (Spinal)

EXPERIMENTAL

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

Device: 20 Hz rTMS (Brain); Device: Anode tsDCS (Spinal)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Device: iTBS rTMS (Brain); Device: Anode tsDCS (Spinal)

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

EXPERIMENTAL

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

Device: iTBS rTMS (Brain); Device: iTBS (Spinal)

sham (no stimulation on brain nor spinal)

SHAM COMPARATOR

First part Sham stimulation. No second part

Device: sham

Interventions

20 Hz rTMS (Brain) DEVICE

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

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

iTBS rTMS (Brain) DEVICE

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

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

Anode tsDCS (Spinal) DEVICE

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

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

20 Hz current square-wave pulses (Spinal) DEVICE

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

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

iTBS (Spinal) DEVICE

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

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

sham DEVICE

with sham stimulation on brain and spinal.

sham (no stimulation on brain nor spinal)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical university Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chien-Hung Lai, MD PhD

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Hung Lai, MD PhD

CONTACT

886-2-27372181; chlai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 11, 2019
• Study Start: December 9, 2019
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)