Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury - Trial NCT06242873
Access comprehensive clinical trial information for NCT06242873 through Pure Global AI's free database. This phase not specified trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. and is currently Recruiting. The study focuses on Spinal Cord Injuries. Target enrollment is 20 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Timeline & Enrollment
N/A
Mar 03, 2022
Dec 30, 2024
Primary Outcome
Timed Up and Go (TUG),10-Meter Walk Test (10MWT),Walking Index for Spinal Cord Injury II (WISCI II),6-Minute Walk Test (6MWT)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06242873
Non-Device Trial