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

Completed · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT03384017

Run by

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

People needed

11

Starts

2017-01-05

Expected to finish

2020-10-28

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

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

Full record on ClinicalTrials.gov

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