Stimulation to Enhance Walking Post-SCI

February 24, 2025 updated by: University of Florida

Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury

This pilot study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.

Study Overview

Status

Status

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

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

The purpose of this pilot study is to investigate the effects of transcutaneous direct current stimulation (tsDCS) on locomotor function and rehabilitation outcomes in individuals with incomplete spinal cord injury (ISCI). tsDCS is a mild, non-invasive form of electrical stimulation that can alter spinal cord excitability.

Specific Aim 1: To test the hypothesis that tsDCS applied during walking will improve motor activation in adults with chronic ISCI. A random order, double blind cross-over study will be conducted across two test sessions to compare the immediate effects of two dosages of tsDCS during walking. To assess motor activation, the primary outcome measure will be lower extremity surface electromyography.

Specific Aim 2 (Interventional): To test the hypothesis that tsDCS applied during 16 sessions of locomotor training will improve functional walking outcomes. Participants will be randomized to receive 16 sessions of locomotor training with one of the two tsDCS dosages. The primary outcome is walking function as measured by standardized clinical tests of walking speed and endurance.

To address the aims of the study, the investigators will use a two-part study design. Following phone and in-person screenings and physician approval, individuals will provide informed consent to the study procedures. In the first part, participants will complete two separate testing sessions, presented in random order, that involve up to 30 minutes of tsDCS at one of two dosages levels while walking. The researchers will assess changes in motor activation before and at the end of the period of walking. For the second part, participants will be randomized to receive 16 sessions of locomotor training with one of the two dosages of tsDCS. Before and after the 16-session intervention (i.e., at baseline and post intervention), the study team will assess functional outcomes through standardized tests of walking speed and endurance.

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 (Actual)

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.
8

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 Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Brooks Rehabilitation Hospital

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Single spinal cord injury (duration >1 year) classified as neurologic level T12 or above based on the International Standards for the Neurologic Classification of Spinal Cord Injury, and classified on the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) as 'C' or 'D' motor incomplete
  • Capable of ambulating 10 feet with or without the use of gait devices, braces, or the assistance of one person
  • Medically stable with no acute illness or infection
  • Able to provide informed consent

Exclusion Criteria:

  • Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
  • Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
  • Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
  • Lower extremity joint contractures limiting the ability to stand upright and practice walking
  • Skin lesions or wounds affecting participation in walking rehabilitation
  • Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
  • Severe spasticity or uncontrolled movements limiting participation in walking rehabilitation
  • Body weight or height that is incompatible with safe use of a support harness and body weight support system
  • Pain that limits walking or participation in walking rehabilitation
  • Current participation in rehabilitation to address walking function
  • Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
  • Legal blindness or severe visual impairment
  • Known pregnancy
  • Implanted metal hardware below the level of the 8th thoracic vertebrae

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: Sequential 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.
Experimental: Interventional effects: Higher dosage
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Device: Soterix Medical tsDCS stimulator
tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Other: Locomotor training
Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
Experimental: Immediate effects low dose tsDCS
Participants will receive one session of walking with a lower dosage of stimulation using the Soterix Medical tsDCS stimulator. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
Device: Soterix Medical tsDCS stimulator
tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Other: Locomotor training
Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
Experimental: Immediate effects higher dose tsDCS
Participants will receive one session of walking with a higher dosage of stimulation using the Soterix Medical tsDCS stimulator. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
Device: Soterix Medical tsDCS stimulator
tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Other: Locomotor training
Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
Experimental: Interventional effects: Lower dosage
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Device: Soterix Medical tsDCS stimulator
tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Other: Locomotor training
Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.

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
Change in 10-Meter Walk Test (Interventional)
Time Frame: Baseline; Week 4
Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.
Baseline; Week 4
Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)
Time Frame: Baseline; 1 hour
The change in normalized amplitude of muscle activation recorded from the right ankle plantar flexor muscles (soleus and gastrocnemius) will be reported. EMGs will be recorded during speed-matched trials during walking on a treadmill. The normalized mean activation during single limb stance will be quantified for each step and averaged. For each participant, the change in activation will be quantified by subtracting activation pre training from post-training activation. The mean change and standard deviation of change will be reported for each group.
Baseline; 1 hour

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
Change in 6-Minute Walk Test (Interventional)
Time Frame: Baseline; Week 4
The 6-Minute Walk Test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
Baseline; Week 4

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.
University of Florida

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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Brooks Rehabilitation

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: Emily Fox, PT, PhD, University of Florida

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.
April 1, 2019

Primary Completion (Actual)

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.
September 2, 2021

Study Completion (Actual)

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.
September 5, 2022

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 9, 2018

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 9, 2018

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.
October 11, 2018

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.
March 25, 2025

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.
February 24, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • IRB201801582 -N -A
  • NIH/NICHD 5P2CHD08685 (Other Grant/Funding Number: REACT Center Pilot Studies Program)
  • OCR16206 (Other Identifier: UF ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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