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NCT06242873 · ClinicalTrials.gov registry record · NA
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
A NA study of Spinal Cord Injuries, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06242873: Recruiting NA study of Spinal Cord Injuries, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT06242873 is a NA study of Spinal Cord Injuries that is actively recruiting participants, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 20 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06242873, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measures walking function, balance, and mobility.
Conditions Studied
Interventions
- OTHER Gait training with/without TSCS
Study Locations (1)
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What NCT06242873 shows while recruiting
NCT06242873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Gait training with/without TSCS is the first listed.
NCT06242873 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06242873 about?
NCT06242873 is a clinical study titled "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 e...
What is the current status of trial NCT06242873?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2022-03-03. Estimated completion is 2026-12-30.
What conditions does trial NCT06242873 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT06242873?
The interventions under investigation include: Gait training with/without TSCS (OTHER).
Who is sponsoring clinical trial NCT06242873?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06242873 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06242873's enrollment target sits among peer trials
20 126th of 202 higher than 66 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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