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

Spinal Cord Injuries Clinical Trial

— TSCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384017
• Other study ID #: IRB00053916
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: October 28, 2020

Study information

• Verified date: February 2021
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 28, 2020
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Rebecca Martin, OTR/L, OTD, CPAM	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking speed	10-Meter Walk Test	at the start, week 4, and week 8
Secondary	Change in walking capacity	Timed Up and Go	at the start, week 4, and week 8
Secondary	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
Secondary	Change in walking endurance	6-Minute Walk Test	at the start, week 4, and week 8