Recruiting

Transcutaneous Spinal Cord Stimulation

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Code:

NCT06242873

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 3 - 16

Healthy Volunteers: Not accepted

Interventions

Gait training with/without TSCS

Study Details

Brief 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. 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

Study ID

NCT06242873

Start date

Mar 3, 2022

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcutaneous Spinal Cord Stimulation and Gait Training

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.

sham comparator: Transcutaneous Spinal Cord Stimulation within a single session

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.

Interventions

Gait training with/without TSCS

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).

Primary outcome measure

  • Timed Up and Go (TUG) [ Time Frame: session 1, 6, 12, 18, and 24 (5-8 weeks total) ]
  • 10-Meter Walk Test (10MWT) [ Time Frame: session 1, 6, 12, 18, and 24 (5-8 weeks total) ]
  • Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: session 1, 6, 12, 18, and 24 (5-8 weeks total) ]
  • 6-Minute Walk Test (6MWT) [ Time Frame: session 1, 6, 12, 18, and 24 (5-8 weeks total) ]

Central Contacts and Locations

Central contacts

Shannon M Inches

443-923-9235inches@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Shannon Inches

443-923-9235

Principal Investigator:

Rebecca Martin, OTR/L, OTD, CPAM

More Information

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Transcutaneous Spinal Cord Stimulation (TSCS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-03-02.