StrokeNCT03714282
Noninvasive Spinal Stimulation in Stroke
A study testing Noninvasive spinal stimulation with gait training and Conventional gait training in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Noninvasive spinal stimulation with gait training and Conventional gait 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
- 18 Oct 2018to 14 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Healthy Control Group Inclusion Criteria:
- Age 18 or older
- Able and willing to give written consent and comply with study procedures
Healthy Control Group Exclusion Criteria:
- No history of cerebrovascular accidents or neurological degenerative pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- Pregnant or nursing
- Skin allergies or irritation; open wounds
- Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
Stroke Group Inclusion Criteria:
- Participants are 18 years of age or older
- Participants are at least 4 weeks post stroke
- Participants with hemiplegia secondary to a single stroke
- Functional Ambulation Category of 2 or greater - Patient needs continuous or intermittent support of one person to help with balance and coordination.
- Participants are able to provide informed consent
- Participants are not currently receiving regular physical therapy services
Stroke Group Exclusion Criteria:
- Individuals less than18 years of age
- Individuals less than 4 weeks post stroke
- Individuals with ataxia
- Individuals with multiple stroke history
- Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA)
- Botox injection in lower extremity within the last 4 months
- Modified Ashworth score of 3 or greater in lower extremity
- Pregnancy or nursing
- Pacemaker or anti-spasticity implantable pumps
- Active pressure sores
- Unhealed bone fractures
- Peripheral neuropathies
- Painful musculoskeletal dysfunction due to active injuries or infections
- Severe contractures in the lower extremities
- Medical illness limiting the ability to walk
- Active urinary tract infection
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Metal implants in their spine TMS Specific Criteria (see Safety Screening Questionnaire for Transcranial Magnetic Stimulation)
- Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Suffers unexplained, recurring headaches
- Had a seizure in the past unrelated to the stroke event, or has epilepsy
- Skull abnormalities or fractures
- Suffered a concussion within the last 6 month
- Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
Read the detailed description
OBJECTIVES:
- To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke
- To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneous non-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke
- Conditions
- Stroke
- Being tested
- Noninvasive spinal stimulation with gait training, Conventional gait training
- Keywords
- Spinal cord stimulation, electrical stimulation, locomotion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive spinal stimulation with gait trainingDevice
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
Conventional gait trainingDevice
May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Spinal Stimulation with Gait Training | Experimental | May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Receives: Device: Noninvasive spinal stimulation with gait training |
| Conventional Gait Training | Active comparator | May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Receives: Device: Conventional gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Step-length Symmetry Using Symmetry Index
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in Swing-time Symmetry
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Secondary outcomes (4)
Change in 10 Meter Walk Test - Self-selected Velocity
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in 10 Meter Walk Test - Fast Velocity
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in 6 Minute Walk Test
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in PCI During 6 Minute Walk Test
Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency.
Measured: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start18 Oct 2018
- Primary completion14 May 2020
- Study completion14 May 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714282
- Sponsor's protocol ID
- STU00206430
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2018
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.
PubMed 38561821
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
- ClinicalTrials.gov ID
- NCT03714282
- Acronym / sponsor ID
- STU00206430
- Conditions
- Stroke
- Keywords
- Spinal cord stimulation, electrical stimulation, locomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 17 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
Detailed description
OBJECTIVES:
- To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke
- To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneous non-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Spinal Stimulation with Gait Training | Experimental | Device: Noninvasive spinal stimulation with gait trainingMay receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
| Conventional Gait Training | Active comparator | Device: Conventional gait trainingMay receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Noninvasive spinal stimulation with gait trainingTranscutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities. | Device | Noninvasive Spinal Stimulation with Gait Training |
| Conventional gait trainingMay receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. | Device | Conventional Gait Training |
Primary outcome
Change in Step-length Symmetry Using Symmetry Index
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
Change in Swing-time Symmetry
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
4 secondary outcomes
Change in 10 Meter Walk Test - Self-selected Velocity
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in 10 Meter Walk Test - Fast Velocity
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in 6 Minute Walk Test
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Change in PCI During 6 Minute Walk Test
Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38561821Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.
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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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive spinal stimulation with gait training and Conventional gait training in people with Stroke, run by Shirley Ryan AbilityLab 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?
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 17 Mar 2026. 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 17 Mar 2026). 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 Step-length Symmetry Using Symmetry Index (time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)). 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?
On the ClinicalTrials.gov record for NCT03714282, which also lists 1 linked publication.
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 17 Mar 2026.