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

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

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Transcutaneous Spinal Cord Stimulation and Gait Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03384017

IRB00053916

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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11 participants in 1 patient group

TSCS and gait training

Experimental group

Treatment:

Other: Transcutaneous Spinal Cord Stimulation and Gait Training