The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury (TSCS)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Spinal Cord Stimulation and Gait Training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
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
Sites / Locations
- Rebecca Martin, OTR/L, OTD, CPAM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TSCS and gait training
Arm Description
Outcomes
Primary Outcome Measures
Change in walking speed
10-Meter Walk Test
Secondary Outcome Measures
Change in walking capacity
Timed Up and Go
Change in level of assistance and assistive device for walking
Walking Index for Spinal Cord Injury II
Change in walking endurance
6-Minute Walk Test
Full Information
NCT ID
NCT03384017
First Posted
December 12, 2017
Last Updated
February 16, 2021
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03384017
Brief Title
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Acronym
TSCS
Official Title
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
October 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
All assessors will be blind to intervention
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TSCS and gait training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Transcutaneous Spinal Cord Stimulation and Gait Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking speed
Description
10-Meter Walk Test
Time Frame
at the start, week 4, and week 8
Secondary Outcome Measure Information:
Title
Change in walking capacity
Description
Timed Up and Go
Time Frame
at the start, week 4, and week 8
Title
Change in level of assistance and assistive device for walking
Description
Walking Index for Spinal Cord Injury II
Time Frame
at the start, week 4, and week 8
Title
Change in walking endurance
Description
6-Minute Walk Test
Time Frame
at the start, week 4, and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rebecca Martin, OTR/L, OTD, CPAM
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
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