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Spinal cord stimulation with walking practice for children with incomplete spinal cord injury

Tests spinal cord stimulation during walking practice in children with incomplete spinal cord injury.

Key facts

Who runs it
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Where
Baltimore, United StatesSee the site
Trial code
Registry title
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
Status
Recruiting
People taking part
20 people, planned
Started
3 Mar 2022
Expected to end
30 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Gait training with/without TSCS
Record updated
2 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with an incomplete spinal cord injury that is not getting worse. It tests skin-surface spinal cord stimulation together with walking training.

Age
3 to 16 years
Sex
All sexes
Disease stage
Incomplete spinal cord injury, AIS grade C or D, injury level above T10, at least 6 months after the injury. Must be able to stay upright for more than 30 minutes and move one leg forward when standing (braces and walking aids allowed). Must be medically stable, with no hospital stays in the last 3 months.

Main reasons for not taking part

  • Spinal cord injury or disease that is getting worse, such as multiple sclerosis
  • Open wounds or a cardiac pacemaker/defibrillator
  • Active cancer
  • Limited joint movement that affects walking training, or no leg reflexes
  • Pregnancy

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)
  • Cardiac pacemaker/defibrillator
  • Active cancer diagnosis
  • Active wounds
  • Range of motion limits impacting gait training
  • Absent LE reflexes
  • Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 16 years old?

Where in United States

  • Kennedy Krieger InstituteBaltimore, United StatesContact: Shannon InchesTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Transcutaneous Spinal Cord Stimulation and Gait TrainingTreatment being tested

    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.

    Treatment: Gait training with/without TSCS

  • Transcutaneous Spinal Cord Stimulation within a single sessionSham treatment, for comparison

    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.

    Treatment: Gait training with/without TSCS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.
Plain-language title
Spinal cord stimulation with walking practice for children with incomplete spinal cord injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06242873, who can take part
Record updated
2 March 2026