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NCT06242873
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
NA trial testing Gait training with/without TSCS in Spinal Cord Injuries in 20 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 3 March 2022 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gait training with/without TSCS
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Who can join
Adults 3 to 16, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06242873
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
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- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Hugo W. Moser Research Institute at Kennedy Krieger, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06242873 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Last refreshed: 2 March 2026
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