SCI - Spinal Cord InjuryNCT03702842
Stimulation to Enhance Walking Post-SCI
A study testing Soterix Medical tsDCS stimulator and Locomotor training in people with SCI - Spinal Cord Injury and Incomplete Spinal Cord Injury, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SCI - Spinal Cord Injury, Incomplete Spinal Cord Injury
- What is being tested?
- Soterix Medical tsDCS stimulator and Locomotor training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
About this study
Official title: 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.
Read the 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.
- Being tested
- Soterix Medical tsDCS stimulator, Locomotor training
- Keywords
- walking, locomotor training, rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix Medical tsDCS stimulatorDevice
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.
Locomotor trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate effects low dose tsDCS | Experimental | 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. Receives: Device: Soterix Medical tsDCS stimulator; Other: Locomotor training |
| Immediate effects higher dose tsDCS | Experimental | 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. Receives: Device: Soterix Medical tsDCS stimulator; Other: Locomotor training |
| Interventional effects: Lower dosage | Experimental | 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. Receives: Device: Soterix Medical tsDCS stimulator; Other: Locomotor training |
| Interventional effects: Higher dosage | Experimental | 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. Receives: Device: Soterix Medical tsDCS stimulator; Other: Locomotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-Meter Walk Test (Interventional)
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.
Measured: Baseline; Week 4
Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)
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.
Measured: Baseline; 1 hour
Secondary outcomes (1)
Change in 6-Minute Walk Test (Interventional)
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.
Measured: Baseline; Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Apr 2019
- Primary completion2 Sep 2021
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brooks Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Emily Fox, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702842
- Sponsor's protocol ID
- IRB201801582 -N -A
- Other IDs
- NIH/NICHD 5P2CHD08685, OCR16206
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2018
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03702842
- Acronym / sponsor ID
- IRB201801582 -N -A
- Keywords
- walking, locomotor training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brooks Rehabilitation
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate effects low dose tsDCS | Experimental | Device: Soterix Medical tsDCS stimulator, Other: Locomotor trainingParticipants 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. |
| Immediate effects higher dose tsDCS | Experimental | Device: Soterix Medical tsDCS stimulator, Other: Locomotor trainingParticipants 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. |
| Interventional effects: Lower dosage | Experimental | Device: Soterix Medical tsDCS stimulator, Other: Locomotor trainingAfter 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. |
| Interventional effects: Higher dosage | Experimental | Device: Soterix Medical tsDCS stimulator, Other: Locomotor trainingAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soterix Medical tsDCS stimulatortsDCS 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. | Device | Immediate effects higher dose tsDCS, Immediate effects low dose tsDCS, Interventional effects: Higher dosage, Interventional effects: Lower dosage |
| Locomotor trainingParticipants 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. | Other | Immediate effects higher dose tsDCS, Immediate effects low dose tsDCS, Interventional effects: Higher dosage, Interventional effects: Lower dosage |
Primary outcome
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.
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.
1 secondary outcome
Change in 6-Minute Walk Test (Interventional)
Time frame: Baseline; Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Fox, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix Medical tsDCS stimulator and Locomotor training in people with SCI - Spinal Cord Injury and Incomplete Spinal Cord Injury, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10-Meter Walk Test (Interventional) (time frame: Baseline; Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.