Spinal Cord InjuriesNCT06242873
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
A study testing Gait training with/without TSCS in people with Spinal Cord Injuries, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Gait training with/without TSCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-16
- ≥ 6 months post injury
- Non-progressive SCI
- American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3
- Neurologic level above T10
- Tolerates upright position for >30 minutes
Show all 9Show fewer
- Able to advance one lower extremity (LE) when in standing, bracing and assistive device allowed
- Medically stable (no hospitalizations in last 3 mos.)
- Able to comply with The International Standards for neurological and functional Classification of Spinal Cord Injury (ISNCSCI) exam
Who cannot join
- Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
- Active wounds
- Range of motion limits impacting gait training
- Cardiac pacemaker/defibrillator
- Active cancer diagnosis
- Absent LE reflexes
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Shannon Inches, 443-923-9235
Rebecca Martin, OTR/L, OTD, CPAM
About this study
Official title: Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions.
Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation.
Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.
- Conditions
- Spinal Cord Injuries
- Being tested
- Gait training with/without TSCS
- Keywords
- Transcutaneous Spinal Cord Stimulation (TSCS)
- 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.
Gait training with/without TSCSOther
To assess the safety and impact of paired stimulation and training on gait in children with iSCI, participants will participate in 24 total sessions. Two sessions will involve assessment only and 22 sessions will include two hours of therapy. Sessions will occur at least three times per week, but may be scheduled as many as five times per week. In each session, participants will receive 60 minutes of treadmill training followed by strengthening, segmental task practice, and gait-based interventions. Participants will receive stimulation based on their group assignment (TSCS or sham).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation and Gait Training | Experimental | Transcutaneous Spinal Cord Stimulation (TSCS), TSCS will be applied using an oval electrode placed midline on the skin on the back and two rectangular electrodes placed on the skin over the lower abdomen. There will be a small electrical current through those electrodes for 30 minutes. Receives: Other: Gait training with/without TSCS |
| Transcutaneous Spinal Cord Stimulation within a single session | Sham comparator | Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued. Receives: Other: Gait training with/without TSCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measures walking function, balance, and mobility.
Measured: session 1, 6, 12, 18, and 24 (5-8 weeks total)
10-Meter Walk Test (10MWT)
Measures walking speed.
Measured: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Walking Index for Spinal Cord Injury II (WISCI II)
Measures walking quality, including need for assistive device and physical assistance.
Measured: session 1, 6, 12, 18, and 24 (5-8 weeks total)
6-Minute Walk Test (6MWT)
Measures walking endurance
Measured: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start3 Mar 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Martin, OTR/L, OTD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Martin, OTR/L, OTD, CPAM, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242873
- Sponsor's protocol ID
- IRB00300695
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.
- ClinicalTrials.gov ID
- NCT06242873
- Acronym / sponsor ID
- IRB00300695
- Conditions
- Spinal Cord Injuries
- Keywords
- Transcutaneous Spinal Cord Stimulation (TSCS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions.
Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation.
Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation and Gait Training | Experimental | Other: Gait training with/without TSCSTranscutaneous Spinal Cord Stimulation (TSCS), TSCS will be applied using an oval electrode placed midline on the skin on the back and two rectangular electrodes placed on the skin over the lower abdomen. There will be a small electrical current through those electrodes for 30 minutes. |
| Transcutaneous Spinal Cord Stimulation within a single session | Sham comparator | Other: Gait training with/without TSCSElectrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 3-16
- ≥ 6 months post injury
- Non-progressive SCI
- American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3
- Neurologic level above T10
Key exclusion criteria (7 listed)
- Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
- Active wounds
- Range of motion limits impacting gait training
- Cardiac pacemaker/defibrillator
- Active cancer diagnosis
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 |
|---|---|---|
| Gait training with/without TSCSTo assess the safety and impact of paired stimulation and training on gait in children with iSCI, participants will participate in 24 total sessions. Two sessions will involve assessment only and 22 sessions will include two hours of therapy. Sessions will occur at least three times per week, but may be scheduled as many as five times per week. In each session, participants will receive 60 minutes of treadmill training followed by strengthening, segmental task practice, and gait-based interventions. Participants will receive stimulation based on their group assignment (TSCS or sham). | Other | Transcutaneous Spinal Cord Stimulation and Gait Training, Transcutaneous Spinal Cord Stimulation within a single session |
Primary outcome
Timed Up and Go (TUG)
Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Measures walking function, balance, and mobility.
10-Meter Walk Test (10MWT)
Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Measures walking speed.
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Measures walking quality, including need for assistive device and physical assistance.
6-Minute Walk Test (6MWT)
Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)
Measures walking endurance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Rebecca Martin, OTR/L, OTD, CPAM principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with/without TSCS in people with Spinal Cord Injuries, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Inches (443-923-9235, inches@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)). The study lists 4 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 2 Mar 2026.