Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury

NCT06242873 | Recruiting DMC

• 1 other identifier: IRB00300695
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Transcutaneous Spinal Cord Stimulation (TSCS)

Outcome Measures

Primary Outcomes (4)

• Timed Up and Go (TUG)

  Measures walking function, balance, and mobility.

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

• 10-Meter Walk Test (10MWT)

  Measures walking speed.

  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.

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

• 6-Minute Walk Test (6MWT)

  Measures walking endurance

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

Study Arms (2)

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.

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.

Other: Gait training with/without TSCS

Interventions

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).

Transcutaneous Spinal Cord Stimulation and Gait Training; Transcutaneous Spinal Cord Stimulation within a single session

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Rebecca Martin, OTR/L, OTD, CPAM

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon M Inches

CONTACT

443-923-9235; inches@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 5, 2024
• Study Start: March 3, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)