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NCT Number: NCT06242873

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Rebecca Martin, OTR/L, OTD, CPAM

PRINCIPAL_INVESTIGATOR

Shannon Inches

CONTACT

443-923-9235

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait training with/without TSCS

Other

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 outcomes

  1. Timed Up and Go (TUG)

    Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking function, balance, and mobility.

  2. 10-Meter Walk Test (10MWT)

    Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking speed.

  3. 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.

  4. 6-Minute Walk Test (6MWT)

    Time frame: session 1, 6, 12, 18, and 24 (5-8 weeks total)

    Measures walking endurance

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon M Inches

CONTACT

[email protected]

443-923-9235

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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