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Understanding and Enhancing Human Health and Movement

27. juli 2026 opdateret af: Nathan Makowski, Louis Stokes VA Medical Center
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

Studieoversigt

Detaljeret beskrivelse

The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance.

This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence.

A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rekruttering
        • Louis Stokes Cleveland VA Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Skeletal maturity and ability to sign informed consent (>18 years)
  • Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
  • Innervated and excitable lower extremity and trunk musculature
  • Adequate social support and stability
  • Willingness to comply with follow-up procedures
  • Time post injury greater than six months
  • Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
  • Neurologically stable as determined by a physician

Exclusion Criteria:

  • Non-English speaking
  • Females who are pregnant
  • Current pressure injuries that would be exacerbated by study activities
  • Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
  • History of spontaneous fractures or other evidence of excessively low bone density
  • History of vestibular dysfunction, balance problems, or spontaneous falls
  • Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
  • Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension
  • Presence of a demand pacemaker or cardiac defibrillator
  • Any other medical or psychological condition that would be a contraindication
  • Current pressure ulcers
  • Significant range of motion limitations that would compromise study activities
  • Body habitus that would compromise study activities

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neural Stimulation
This phase includes the use of neural (electrical) stimulation during everyday activities such as sitting, standing, walking, and exercise
implanted electrical stimulation device
Andre navne:
  • IST-16
  • IST-12
  • IRS-8
  • Spiral Cuff

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Difference in Max Standing Time
Tidsramme: Study completion - an average of 1 year
Study completion - an average of 1 year
Difference in Max Walking distance
Tidsramme: Study completion - an average of 1 year
Study completion - an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. marts 2021

Primær færdiggørelse (Anslået)

21. marts 2031

Studieafslutning (Anslået)

21. marts 2034

Datoer for studieregistrering

Først indsendt

17. juli 2026

Først indsendt, der opfyldte QC-kriterier

27. juli 2026

Først opslået (Faktiske)

31. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner