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Completed

NCT Number: NCT03384017

The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.

Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rebecca Martin, OTR/L, OTD, CPAM

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • >1 year post SCI
  • Non-progressive SCI
  • Neurological level above T10
  • Tolerates upright position for >30 minutes
  • Medically stable (no hospitalizations in last 3 months)
  • Able to comply with procedures and follow up
  • Are legally able to make their own health care decisions

Exclusion criteria

  • Progressive SCI/D (MS, ALS, ADEM, etc.)
  • Open wounds at stimulation site
  • Pregnant women
  • ROM limitations impacting gait training
  • Cardiac pacemaker/defibrillator
  • Active cancer diagnosis
  • Currently receiving TSCS
  • Evidence of uncontrolled autonomic dysreflexia
  • Non-English speaking subjects will not be targeted

Treatment and study plan

Transcutaneous Spinal Cord Stimulation and Gait Training

Other

TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation.

Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session.

Primary outcomes

  1. Change in walking speed

    Time frame: at the start, week 4, and week 8

    10-Meter Walk Test

Secondary outcomes

  1. Change in walking capacity

    Time frame: at the start, week 4, and week 8

    Timed Up and Go

  2. Change in level of assistance and assistive device for walking

    Time frame: at the start, week 4, and week 8

    Walking Index for Spinal Cord Injury II

  3. Change in walking endurance

    Time frame: at the start, week 4, and week 8

    6-Minute Walk Test

Sponsors and collaborators

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Other

Registry information

Acronym: TSCS

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 27, 2017
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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