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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Transcutaneous Spinal Cord Stimulation and Gait Training

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Rebecca Martin, OTR/L, OTD, CPAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TSCS and gait training

Other: Transcutaneous Spinal Cord Stimulation and Gait Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking speed	10-Meter Walk Test	at the start, week 4, and week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking capacity	Timed Up and Go	at the start, week 4, and week 8
Change in level of assistance and assistive device for walking	Walking Index for Spinal Cord Injury II	at the start, week 4, and week 8
Change in walking endurance	6-Minute Walk Test	at the start, week 4, and week 8

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: IRB00053916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No