Transspinal Stimulation Plus Locomotor Training for SCI
27. juli 2026 oppdatert av: Maria Knikou, PT, MBA, PhD, City University of New York
Priming med høyfrekvent trans-spinal stimulering for å øke lokomotoriske fordeler ved ryggmargsskade
Bevegelighetstrening brukes ofte med sikte på å forbedre kortikospinal funksjon og gangevne hos personer med ryggmargsskade.
Spennende nok kan fordelene med lokomotorisk trening forsterkes av ikke-invasiv elektrisk stimulering av ryggmargen og forbedre motorisk utvinning ved SCI.
Denne studien vil sammenligne effekten av priming lokomotorisk trening med høyfrekvent ikke-invasiv thoracolumbar spinal stimulering.
Hos personer med motorisk ufullstendig SCI vil det bli utført en rekke kliniske og elektriske tester av hjerne- og ryggmargsfunksjon før og etter 40 økter med bevegelsestrening hvor spinalstimulering leveres rett før enten liggende eller under stående.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Ryggmargsskade (SCI) svekker i stor grad stå- og gåevnen, noe som alvorlig kompromitterer dagliglivets aktiviteter. Selv om disse underskuddene er delvis forbedret av lokomotorisk trening, selv etter flere treningsøkter, vedvarer unormal muskelaktivitet og koordinasjon fortsatt. Dermed kan ikke lokomotorisk trening alene optimalisere den nevronale plastisiteten som kreves for å styrke synapsene som forbinder hjernen, ryggmargen og lokale kretsløp. Som sådan er behandlingsintervensjoner som effektivt fremmer nevromodulering av spinal lokomotoriske nettverk og styrker nevrale tilkobling av den skadde menneskelige ryggmargen i kombinasjon med fysisk rehabilitering sterkt nødvendig. Det er foreslått at transkutan ryggmargsstimulering (transspinal) som en metode for synergistisk å "prime" nervesystemet for å bedre svare på bevegelsestrening. Transspinal stimulering endrer motoneuron-eksitabilitet over flere ryggradssegmenter, en forutsetning for fungerende synkende og lokale innganger. Det er viktig at det er ukjent om samtidig behandling med transspinal stimulering og bevegelsestrening maksimerer motorisk utvinning etter SCI. Målet med denne kliniske studien er å bruke høyfrekvent (30 Hz) transspinal stimulering for å prime lokomotorisk trening og til slutt forbedre stående, gå og generell funksjon hos personer med kronisk ufullstendig SCI (iSCI). Førtifem individer med iSCI vil gjennomgå 40 økter med kroppsvektstøttet trinntrening med høyfrekvent transspinal stimulering. Deltakerne vil bli randomisert til å motta transspinal stimulering under stående (ekte eller falske) eller mens de ligger på rygg (ekte). Mål 1 evaluerer hvordan priming av lokomotorisk trening med høyfrekvent transspinal stimulering i SCI endrer kortikomotoneuronal tilkoblingsstyrke, som indikert av motorisk fremkalte potensialer registrert fra bena.
Mål 2 evaluerer hvordan priming av lokomotorisk trening med høyfrekvent transspinal stimulering i iSCI påvirker reorganisering og passende engasjement av spinale nevronale kretser. Til slutt evaluerer Mål 3 aktivitetsbasert motorisk funksjon, evne til å stå og gå og livskvalitet. Disse resultatene vil støtte oppfatningen om at tonisk høyfrekvent transspinal stimulering styrker kortikomotoneuronal tilkobling og forbedrer organisering av spinalkretser gjennom holdningsavhengig kortikospinal nevroplastisitet. Det er forventet at informasjonen som er oppnådd fra denne mekanistiske kliniske studien vil ha stor innvirkning på klinisk praksis. Dette er fordi i kliniske omgivelser i den virkelige verden kan ikke-invasiv transspinal stimulering implementeres enklere og mer bredt enn invasiv epidural stimulering.
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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Staten Island, New York, Forente stater, 10314
- Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
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The Bronx, New York, Forente stater, 10468
- Veterans Affairs Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år til 66 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Vilje til å overholde alle studieprosedyrer og tilgjengelighet under studiets varighet.
- Evne til å forstå samtykkeskjemaet, og signere samtykkeskjemaet.
- Mann eller kvinne, alderen 18-70 år.
- Ved god generell helse som dokumentert av sykehistorien.
- Diagnostisert med motorisk ufullstendig SCI (AIS C-D).
- Benmineraltetthet i hoften (proksimal femur) T-score
- Lesjon over thorax (T) 10 for å sikre fraværende nedre motoneuronlesjon.
- Tilstedeværelse av senereflekser for å kunne fremkalle soleus H-refleks.
- Fraværende permanente ankelleddkontrakturer som forhindrer passiv eller aktiv ankelbevegelse fordi kortikospinal og spinal eksitabilitet er basert på ankelvinkelen. Ankelstroppene til Lokomat krever også fleksible ankelledd.
- En diagnose av førstegangs SCI på grunn av traumer, vaskulær eller ortopedisk patologi.
- Tid etter SCI på mer enn 6 måneder.
- Stabil medisinsk tilstand uten hjerte- og lungesykdom eller kognitiv svikt.
Ekskluderingskriterier:
- Supraspinallesjoner.
- Betydelige nevropatier i det perifere nervesystemet.
- Betydelige degenerative nevrologiske lidelser i ryggraden eller ryggmargen.
- AIS A eller B.
- Tilstedeværelse av trykksår.
- Avansert urinveisinfeksjon.
- Neoplastiske eller vaskulære lidelser i ryggraden eller ryggmargen.
- Deltakelse i et pågående forskningsstudie eller nytt rehabiliteringsprogram.
- Gravide kvinner eller kvinner som mistenker at de kan være, eller kan bli gravide, vil bli ekskludert fra deltakelse fordi risikoen for thoracolumbar stimulering til fosteret er ukjent.
- Personer med cochleaimplantater, pacemaker, implantert infusjonsenhet og/eller implanterte stimulatorer av enhver type og formål vil bli ekskludert for å unngå funksjonsfeil på grunn av stimulering.
- Personer med anfallshistorie.
- Medisinske tilstander som øker muligheten for anfall.
- Medisiner som kan endre krampeterskelen.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Ekte transspinal stimulering levert under stående etterfulgt av lokomotorisk trening
Transspinal tonisk stimulering av thoracolumbar-regionen vil bli levert med en frekvens på 30 Hz under stående med etter behov kroppsvektstøtte (BWS) i en stående ramme eller i Lokomat for å sikre sikkerhet.
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Femten personer med ryggmargsskade vil motta 40 daglige økter på 30 minutter med ikke-invasiv høyfrekvent (f.eks. 30 Hz) transkutan transspinal stimulering under stående etterfulgt av 30 minutter med assistert stepping robotgangtrening.
Før og etter trening vil standardiserte kliniske og nevrofysiologiske tester bli brukt for å vurdere utvinning av sensorimotorisk funksjon.
Andre navn:
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Eksperimentell: Ekte transspinal stimulering levert mens du ligger på ryggen etterfulgt av bevegelsestrening
Transspinal tonisk stimulering vil bli levert med en frekvens på 30 Hz mens du ligger på ryggen.
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Femten personer med ryggmargsskade vil motta 40 daglige økter på 30 minutter med ikke-invasiv høyfrekvent (f.eks. 30 Hz) transkutan transspinal stimulering mens de ligger på rygg på et terapibord, etterfulgt av 30 minutter med assistert stepping robotisk gangtrening.
Før og etter trening vil standardiserte kliniske og nevrofysiologiske tester bli brukt for å vurdere utvinning av sensorimotorisk funksjon.
Andre navn:
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Sham-komparator: Sham transspinal stimulering levert under stående etterfulgt av lokomotorisk trening
En falsk gruppe vil motta transspinal stimulering under stående med en intensitet hvor følelsen er fraværende.
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Femten personer med ryggmargsskade vil motta 40 daglige økter med 30 minutters simulert transspinal stimulering under stående med en intensitet der følelsen er fraværende etterfulgt av 30 minutter med robotgangtrening.
Før og etter trening vil standardiserte kliniske og nevrofysiologiske tester bli brukt for å vurdere utvinning av sensorimotorisk funksjon.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Plasticity of Spinal Neuronal Networks - Homosynaptic Depression
Tidsramme: 4-6 months
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Soleus H-reflexes following posterior tibial nerve stimulation with a 1-ms monophasic pulse were recorded with subjects seated and stimuli delivered every 1 s (1.0 Hz), 3 s (0.33 Hz), 5 s (0.2 Hz), 8 s (0.125 Hz), and 10s (0.1 Hz).
Results for each interval vs 0.1 Hz shown.
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4-6 months
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Plasticity of Spinal Neuronal Networks - Presynaptic Inhibition
Tidsramme: 4-6 months
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Presynaptic inhibition was assessed with a conditioning pulse train of 4 pulses with 9 ms duration, delivered to the CPN at the C-T intervals of 20, 60, or 100 ms. These C-T intervals were selected because the reflex inhibition produced at the intermediate C-T intervals is predominantly presynaptic. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention. |
4-6 months
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Plasticity of Spinal Neuronal Networks - Reciprocal Inhigition
Tidsramme: 4-6 months
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To assess restoration of reciprocal Ia inhibition, soleus H-reflexes were recorded following common peroneal nerve (CPN) stimulation at short conditioning-test (C-T) intervals of 0, 1, 2, 3, and 4 ms. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention. |
4-6 months
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Plasticity of Corticospinal Networks
Tidsramme: 4-6 months
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Neurophysiological measurements assessing changes in corticospinal excitability from the interventions by recording responses to single-pulse transcranial magnetic stimulation (TMS) at rest and during robotic-assisted stepping. The tibialis anterior resting motor threshold (RMT) was established and corresponded to the lowest TMS maximal stimulator output that induced reproducible evoked potentials of at least ~50 µV in 4 out of 5 consecutive single TMS pulses. RMTs (percentage of maximal stimulator output) are shown pre- and post-intervention. |
4-6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Ambulatory Function
Tidsramme: 4-6 months
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Change in 10-meter timed test (seconds required to complete 10-meter walk) between baseline and post-intervention.
Fewer seconds means faster (better) gait.
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4-6 months
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Balance
Tidsramme: 4-6 months
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Changes in Berg Balance Scale score between baseline and post-intervention.
Scale scores between 0 and 56.
Higher scores mean better balance.
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4-6 months
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Autonomic Function
Tidsramme: 4-6 months
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SCIM III Bladder and Bowel management subscores Bladder subscore rated 0-15 (higher means better bladder function).
Bowel subscore rated 0-10 (higher means better bowel function).
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4-6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Noam Y. Harel, MD, PhD, Bronx Veterans Medical Research Foundation
- Hovedetterforsker: Maria Knikou, PT, PhD, Research Foundation of the City University of New York
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
- Knikou M, Murray LM. Repeated transspinal stimulation decreases soleus H-reflex excitability and restores spinal inhibition in human spinal cord injury. PLoS One. 2019 Sep 26;14(9):e0223135. doi: 10.1371/journal.pone.0223135. eCollection 2019.
- Sayenko DG, Rath M, Ferguson AR, Burdick JW, Havton LA, Edgerton VR, Gerasimenko YP. Self-Assisted Standing Enabled by Non-Invasive Spinal Stimulation after Spinal Cord Injury. J Neurotrauma. 2019 May 1;36(9):1435-1450. doi: 10.1089/neu.2018.5956. Epub 2018 Dec 15.
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- Dixon L, Ibrahim MM, Santora D, Knikou M. Paired associative transspinal and transcortical stimulation produces plasticity in human cortical and spinal neuronal circuits. J Neurophysiol. 2016 Aug 1;116(2):904-16. doi: 10.1152/jn.00259.2016. Epub 2016 Jun 8.
- Knikou M. Functional reorganization of soleus H-reflex modulation during stepping after robotic-assisted step training in people with complete and incomplete spinal cord injury. Exp Brain Res. 2013 Jul;228(3):279-96. doi: 10.1007/s00221-013-3560-y. Epub 2013 May 25.
- Smith AC, Mummidisetty CK, Rymer WZ, Knikou M. Locomotor training alters the behavior of flexor reflexes during walking in human spinal cord injury. J Neurophysiol. 2014 Nov 1;112(9):2164-75. doi: 10.1152/jn.00308.2014. Epub 2014 Aug 13.
- Smith AC, Rymer WZ, Knikou M. Locomotor training modifies soleus monosynaptic motoneuron responses in human spinal cord injury. Exp Brain Res. 2015 Jan;233(1):89-103. doi: 10.1007/s00221-014-4094-7. Epub 2014 Sep 10.
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- Knikou M, Smith AC, Mummidisetty CK. Locomotor training improves reciprocal and nonreciprocal inhibitory control of soleus motoneurons in human spinal cord injury. J Neurophysiol. 2015 Apr 1;113(7):2447-60. doi: 10.1152/jn.00872.2014. Epub 2015 Jan 21.
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- Pulverenti TS, Islam MA, Alsalman O, Murray LM, Harel NY, Knikou M. Transspinal stimulation decreases corticospinal excitability and alters the function of spinal locomotor networks. J Neurophysiol. 2019 Dec 1;122(6):2331-2343. doi: 10.1152/jn.00554.2019. Epub 2019 Oct 2.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2021
Primær fullføring (Faktiske)
1. desember 2024
Studiet fullført (Faktiske)
31. desember 2024
Datoer for studieregistrering
Først innsendt
11. mars 2021
Først innsendt som oppfylte QC-kriteriene
18. mars 2021
Først lagt ut (Faktiske)
19. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01HD100544 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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