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

NCT03384017 | Completed DMC

• 1 other identifier: IRB00053916
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change in walking speed

  10-Meter Walk Test

  at the start, week 4, and week 8

Secondary Outcomes (3)

• Change in walking capacity

  at the start, week 4, and week 8

• Change in level of assistance and assistive device for walking

  at the start, week 4, and week 8

• Change in walking endurance

  at the start, week 4, and week 8

Study Arms (1)

TSCS and gait training

EXPERIMENTAL

Other: Transcutaneous Spinal Cord Stimulation and Gait Training

Interventions

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.

TSCS and gait training

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Rebecca Martin, OTR/L, OTD, CPAM

Baltimore, Maryland, 21205, United States

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessors will be blind to intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 27, 2017
• Study Start: January 5, 2017
• Primary Completion: September 14, 2018
• Study Completion: October 28, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)