20 Participants NeededMy employer runs this trial

Electrical vs Transcutaneous Stimulation for Spinal Cord Injury

KM
Overseen ByKatherine Metcalf
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Center for Veterans Research and Education
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Cervical spinal cord injuries (SCI) are the most common form of spinal cord injuries within the veteran population. Losing arm function is a major concern with these injuries. Doctors often use a treatment called functional electrical stimulation (FES) during rehab sessions targeted at improving arm and hand function. For FES, clinicians places sticky pads on the skin over the muscles that need to move. A newer treatment, called transcutaneous spinal stimulation (TSS), places the pads on the skin over the spine instead. This study compares the two treatments in veterans with non-traumatic spinal cord injuries while they are in the hospital's rehab program. The main goal is to see how well each treatment improves arm and hand function, which is measured with the Capabilities of Upper Extremity Test. If TSS works well, it could help veterans regain more arm and hand function which may result in increased independence.

Who Is on the Research Team?

JM

John M Looft, PhD

Principal Investigator

Minneapolis VA

Are You a Good Fit for This Trial?

This trial is for veterans with recent (subacute), non-traumatic spinal cord injuries in the neck area who are currently in a hospital rehab program and have lost some arm or hand function.

Inclusion Criteria

Veterans admitted to the Minneapolis VA Health Care System's SCI inpatient unit for sub-acute rehabilitation following non-traumatic cervical SCI
Veterans are eligible for enrollment within 90 days of the onset of their spinal cord injury
I am 18 years old or older.
See 1 more

Exclusion Criteria

Active implanted medical device for electrical stimulation
Allergy to hydrogel, silicone, latex or other product materials
BMI greater than 40.0 (morbid obesity)
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Electrical Stimulation (FES)
  • Transcutaneous Spinal Stimulation (TSS)

Trial Overview

The study compares two types of electrical stimulation therapies—functional electrical stimulation (FES) using muscle pads, and transcutaneous spinal stimulation (TSS) using spine pads—to see which better improves arm and hand movement during rehabilitation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Transcutaneous spinal stimulationExperimental Treatment1 Intervention
Group II: Functional electrical stimulationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Center for Veterans Research and Education

Lead Sponsor

Trials
13
Recruited
1,700+

Niche Biomedical, Inc. dba ANEUVO

Industry Sponsor

Trials
2
Recruited
40+