Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury

October 27, 2026 updated by: Center for Veterans Research and Education

Comparison of Traditional Functional Electrical Stimulation to Transcutaneous Stimulation on Upper Extremity Outcomes in Patients With Subacute Spinal Cord Injury

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cervical spinal cord injuries (SCI) are the most prevalent form of spinal cord injuries within the veteran population. Cervical spinal cord injuries can result in functional limitations to both the lower and upper extremities. Among cervical SCI patients, addressing loss of function in the upper extremities is an extremely important issue to address. Current strategies to treat cervical spinal cord injuries during sub-acute rehabilitation incorporate functional electrical stimulation (FES), with electrodes placed on the skin directly over the targeted muscle groups. With this study current standard care FES will be compared with a new type of muscle stimulation - transcutaneous spinal stimulation (TSS) using the ExaStim® Stimulation System - where electrodes are placed on the skin over the spine. This study is a randomized controlled trial comparing the experimental use of TSS vs FES/standard care among veterans with non-traumatic spinal cord injury during their inpatient sub-acute stay. Outcome evaluations include physical outcome measures and patient-reported outcomes. The primary outcome measure is the Capabilities of Upper Extremity Test. Data will be collected by staff who are blinded to participants' group assignment. This study will provide evidence on the potential benefits of a promising new rehabilitation treatment modality - TSS - for supporting veterans with cervical SCI in achieving optimal outcomes in function and independence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis VA Health Care Systems
        • Principal Investigator:
          • John M Looft, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Veterans admitted to the Minneapolis VA Health Care System's (MVAHCS) 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.
    • Non-traumatic SCI, level T2 or above; AIS A,B,C,D.
    • Age 18+.

Exclusion Criteria:

  • • Study clinicians determine that the veteran would likely not benefit from FES.

    • Open wounds where electrodes would be placed.
    • Cognitive impairments identified during the consent process indicating a veteran's Inability to comprehend essential information about the study.
    • Contraindications to electrical stimulation (pacemaker, defibrillator, pregnancy, active tissue infection in area of stimulation).
    • Active implanted medical device for electrical stimulation.
    • Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
    • Acute medical conditions under active treatment that would contraindicate standard rehabilitation." History of a non-SCID related neurological condition (stroke, brain injury, etc.) impacting upper extremity.
    • Uncontrolled, severe autonomic dysreflexia.
    • Need for ventilator support.
    • Inability to participate in therapy session >60 minutes.
    • Botulinum toxin injections to the upper limb in prior 3 months.
    • BMI > 40.0 (morbid obesity).
    • Allergy to hydrogel, silicone, latex or other product materials.
    • Uncontrolled cardiopulmonary disease.
    • Uncontrolled epilepsy or seizures.
    • Unmanaged depression, psychiatric disorders or ongoing substance abuse.
    • Participation in another clinical trial that may interfere with this study.
    • Pregnancy is contra-indicated for both TSS and FES. Women of childbearing years will be excluded as the enrollment timeline won't allow time for pregnancy testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Functional electrical stimulation

RTI Xcite
Device: RTI Xcite

Functional electrical stimulation
Experimental: Transcutaneous spinal stimulation

ExaStim
Device: ExaStim

Transcutaneous spinal stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Capabilities of Upper Extremity Test (CUE-T)
Time Frame: Baseline, 4-week, 8-week

A performance measure focused on quantifying upper limb limitations and impairment. The CUE-T assesses 17-19 tasks including reaching, lifting (up to 2kg), wheelchair push up, dynamometer strength testing, and active range of motion. Scoring is scored from 0 (unable) to 4 (no difficulty) with high scores indicating better upper limb function. This measure will be completed by a study staff (licensed physical or occupational therapist) who is blinded to treatment allocation. This instrument typically requires 15-30 minutes to complete. CUE-T evaluation sessions will be video-recorded so that observations of participant activities can be validated for study purposes. These video recordings will be destroyed as soon as the CUE-T assessment score has been finalized (within 2 weeks of completing the CUE-T.)
Baseline, 4-week, 8-week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper Extremity Motor Score UEMS
Time Frame: Baseline, 8-weeks

The UEMS is an upper limb strength assessment of upper limb muscles stratified by spinal nerve level innervation, using traditional manual muscle testing scoring (0-5/5). This requires the participant to demonstrate available movement against gravity, then if full movement is available that motion could be tested against resistance of the tester. If unable to move against gravity the muscles would be tested in gravity eliminated position (ie., horizontal plane) for active range of motion for full/partial range or palpable activity of the targeted muscle group. These tests are consistent with clinical practice to assess spinal cord injury level. This subscale may be performed by the blinded assessor if not completed by clinical staff as part of the ASIA Impairment Scale/International Standards for Neurological Classification of Spinal Cord Injury (AIS/ISNCSCI).
Baseline, 8-weeks
Modified Ashworth Scale for Upper Extremity
Time Frame: Baseline, 8-weeks

This is an impairment scale to measure muscle spasticity or tone in response to passive lengthening of a muscle. It requires the participant to lay supine while study staff, the blinded assessor/therapist, passively moves a joint to lengthen a muscle over a joint's full range of motion over approximately 1 second, or approximately at the speed of gravity. Each joint/muscle tested may be tested up to three times. The scale rates resistance to passive movement from 0 (no increase in tone) to 4 (joint fixed in flexion or extension). For this study, only the upper limb will be tested as part of the protocol.
Baseline, 8-weeks
Capabilities of Upper Extremity Questionnaire CUE-Q
Time Frame: Baseline, 8-weeks

The CUE-Q is a 32-item questionnaire that evaluates functional limitations of the hands and arms using a scale of perceived difficulty from 0 (unable) - 4 (no difficulty). Activities inquired about include reaching, lifting objects, pulling/sliding objects, holding small objects like coins, etc. This may take 5-15 minutes to administer.
Baseline, 8-weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inpatient Rehabilitation Facility Patient Assessment Instrument IRF-PAI (Section GG codes)
Time Frame: Baseline, 8-weeks

This assessment is designed solely for use during inpatient rehabilitation; it replaced the previous use of the FIM measure for inpatient rehabilitation. For this outcome, assessments will be completed by VA clinical therapist(s) who will categorize typical function over a 3-day admission period and during the final three days prior to discharge. This assessment categorizes functional level from 01 (dependent) to 6 (independent). For this study, this assessment will be completed as a portion of clinical assessment, and will include observation of specific functional activities as deemed appropriate & safe for clinical assessment including but not limited to: Self-care (upper body dressing, bathing,, toileting, oral hygiene, eating, etc), mobility ((rolling, sit to lying, lying to sitting edge of bed, sit to stand, chair to chair transfer, toilet transfer, walking various distances, stairs, wheeled mobility, etc), bowel and bladder continence, and health history (falls, pain, etc).
Baseline, 8-weeks
PROMIS Pain Intensity and Pain Interference Scales
Time Frame: Baseline, 8-weeks

Promis Pain Intensity and Interference scales are short form assessments using a Likert scale addressing levels of pain or pain interference from 1 (not at all/never) - 7 (very much/always). These scales would take less than 10 minutes to complete.
Baseline, 8-weeks
Spinal Cord Injury Quality of Life - Resilience SCI-QOL
Time Frame: Baseline, 8-weeks

This assessment focused on measuring quality of life (QOL) across physical, emotional and global health domains using a Likert scale with ratings from 1 (lowest frequency, or never) to 5 (highest frequency or always). This scale is sometimes called the NeuroQOL, and has been updated to be structured like the PROMIS measures where it can be completed via paper forms, short forms, or a computer adaptive testing on a tool such as REDcap. The adaptive testing can take as little as 10 minutes and provides a T-score across a normalized scoring distribution of 100, where the mean is 50.
Baseline, 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Veterans Research and Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Niche Biomedical, Inc. dba ANEUVO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John M Looft, PhD, Minneapolis VA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1904131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

The CRADA associated with this research indicates that the IPD and supporting information can be released after 180 days upon completion of the CRADA. We anticipate having the IPD and supporting information available after that period.

IPD Sharing Access Criteria

The PI and Statistician will review requests.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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