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De klinische studie NCT06272279 voor Ruggenmergletsels, Ruggenmergletsel op C5-C7 niveau, Paraplegie, spinaal, Paraplegia, Incomplete is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Universiteit van ManitobaNeuromodulation With Spinal Stimulation Methods
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De klinische studie NCT06272279 is een interventioneel studie bij Ruggenmergletsels, Ruggenmergletsel op C5-C7 niveau, Paraplegie, spinaal, Paraplegia, Incomplete met de status recruterend. Het doel is om 24 deelnemers te includeren vanaf 1 maart 2024. De studie wordt geleid door de Universiteit van Manitoba en de voltooiing is gepland op 15 februari 2026. Laatste update op ClinicalTrials.gov: 10 februari 2025.
Beknopte samenvatting
This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.
Uitgebreide beschrijving
Purpose of this project
Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).
Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.
corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.
Officiële titel
Neuromodulation With Spinal Stimulation Methods
Aandoeningen
RuggenmergletselsRuggenmergletsel op C5-C7 niveauParaplegie, spinaalParaplegia, IncompleteAndere studie-ID's
- HS23666(B2020:015)
NCT-ID
Startdatum (Werkelijk)
2024-03-01
Laatste update geplaatst
2025-02-10
Verwachte einddatum
2026-02-15
Inschrijving (Geschat)
24
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Basiswetenschap
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Dubbelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelSpinal cord stimulation Spinal cord stimulation will be administered to participants for 15 min. | Spinal Stimulation-dcs transcutaneous spinal stimulation by direct current stimulation Spinal Stimulation-eps transcutaneous spinal stimulation by electrical pulsed stimulation |
SchijncomparatorShamspinal cord stimulation Sham spinal cord stimulation will be administered to participants for 15 min. | Spinal Stimulation-sham DCS sham transcutaneous spinal stimulation by direct current stimulation Sham Spinal Stimulation-eps sham transcutaneous spinal stimulation by electrical pulsed stimulation |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Motor response | H-reflex input output curve | Immediately after stimulation (within 1-15 min) |
Motor evoked potentials | MEP input-output curve | Immediately after stimulation (within 1-15 min) |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Blood pressure | Measured (in arm) with inflatable cuff-automated, standard machine. | During the procedure/stimulation and up to 15 min after stimulation. |
Perception of discomfort due to stimulation | self-reporting on a scale ( the higher, the more discomfort) | During and after procedure/stimulation and up to 15 min after stimulation. |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- spinal cord injury C4 to L4
- ability to understand and follow directions
- history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
Universiteit van Manitoba126 actieve klinische studies om te verkennenCentraal Contactpersoon
Contact: Katinka Stecina, PhD, 204 789 3761, [email protected]
Contact: Kristine Cowley, PhD, 2047893305, [email protected]
2 Studielocaties in 1 landen
Manitoba
University of Manitoba, Winnipeg, Manitoba, R3E 0J9, Canada
Inschrijving op uitnodiging
University of Manitoba, Winnipeg, Manitoba, R3E 0J9, Canada
Katinka Stecina, Ph.D., Contact, 2047893761, [email protected]
Kristine Cowley, Ph.D., Contact, 2047893305, [email protected]
Recruterend