Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242873
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-18
Brief Title:
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
Sponsor:
Hugo W Moser Research Institute at Kennedy Krieger Inc
Organization:
Hugo W Moser Research Institute at Kennedy Krieger Inc
Study Overview
Official Title:
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury Safety Feasibility and Efficacy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None