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Epidural Stimulation and Rehabilitation for Spinal Cord Injury

16. juli 2026 opdateret af: Görkem Açar, Istanbul Gelisim University

Early Functional Change After Epidural Electrical Stimulation Combined With Structured Rehabilitation in Spinal Cord Injury With Conus-Region Involvement: An Exploratory Cohort Analysis

Spinal cord injury involving the conus region often results in severe impairments in mobility, self-care, and bladder and bowel function, substantially reducing independence and quality of life. Epidural electrical stimulation (EES), combined with structured rehabilitation, has emerged as a promising neuromodulation strategy for improving functional recovery; however, evidence in patients with conus-region involvement remains limited. This exploratory cohort study aims to evaluate functional changes following EES integrated with a standardized rehabilitation program in individuals with spinal cord injury involving the conus region. Functional independence is assessed using the Spinal Cord Independence Measure (SCIM) at baseline and during follow-up. The study also evaluates changes in SCIM subdomains related to self-care, respiration and sphincter management, and mobility, while monitoring the safety of EES throughout the rehabilitation period. The findings are expected to provide preliminary evidence regarding the feasibility, safety, and potential functional benefits of combining epidural electrical stimulation with structured rehabilitation in this specific spinal cord injury population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

29

Kontakter og lokationer

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Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34310
        • Istanbul Gelisim University

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population consisted of individuals with chronic spinal cord injury involving the conus region (T12 and/or L1) who received epidural electrical stimulation integrated with a structured rehabilitation program. Twenty-nine participants (20 males and 9 females; age range 17-61 years) with complete baseline and follow-up assessments were included in the final analysis.

Beskrivelse

Inclusion Criteria:

  • Adults and adolescents aged 17 to 61 years.
  • Diagnosis of chronic spinal cord injury involving the conus region (T12 and/or L1).
  • Underwent epidural electrical stimulation (EES) combined with a structured rehabilitation program.
  • Available baseline and follow-up Spinal Cord Independence Measure (SCIM) assessments.
  • Provided written informed consent or consent was obtained from a legally authorized representative.

Exclusion Criteria:

  • Spinal cord injury without conus-region involvement.
  • Missing baseline or follow-up functional assessment data. Incomplete clinical records preventing outcome evaluation.
  • Contraindications to epidural electrical stimulation or inability to participate in the rehabilitation program.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Spinal Cord Injury With Conus-Region Involvement
Participants with chronic spinal cord injury involving the conus region (T12 and/or L1) who underwent epidural electrical stimulation combined with a structured rehabilitation program. Functional outcomes were evaluated using the Spinal Cord Independence Measure (SCIM) over a 6-month follow-up period.
Enhed: Epidural Electrical Stimulation (EES)
Participants received individualized epidural electrical stimulation delivered through an implanted epidural stimulation system in combination with a structured rehabilitation program. Stimulation parameters were adjusted according to clinical response, and rehabilitation included task-oriented exercises, balance training, standing, gait preparation, and functional mobility exercises throughout the 6-month follow-up period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Spinal Cord Independence Measure (SCIM) Score
Tidsramme: Baseline to 6 Months
The primary outcome is the change in total Spinal Cord Independence Measure (SCIM) score between baseline and the 6-month follow-up. The SCIM assesses functional independence in individuals with spinal cord injury, with scores ranging from 0 to 100; higher scores indicate greater functional independence.
Baseline to 6 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in SCIM Self-Care Subscale Score
Tidsramme: Baseline to 6 Months
Assessment of changes in the SCIM Self-Care subscale score.
Baseline to 6 Months
Change in SCIM Respiration and Sphincter Management Subscale Score
Tidsramme: Baseline to 6 Months
Assessment of changes in the SCIM Respiration and Sphincter Management subscale score.
Baseline to 6 Months
Change in SCIM Mobility: Room and Toilet Subscale Score
Tidsramme: Baseline to 6 Months
Assessment of changes in the SCIM Mobility: Room and Toilet subscale score.
Baseline to 6 Months
Change in SCIM Mobility: Indoors and Outdoors Subscale Score
Tidsramme: Baseline to 6 Months
Assessment of changes in the SCIM Mobility: Indoors and Outdoors subscale score.
Baseline to 6 Months
Incidence of Device- or Procedure-Related Adverse Events
Tidsramme: Baseline to 6 Months
Occurrence of major procedure- or device-related adverse events, including wound infection, cerebrospinal fluid leak, lead migration, stimulation intolerance requiring discontinuation, revision surgery, or device explantation during the follow-up period.
Baseline to 6 Months

Samarbejdspartnere og efterforskere

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Sponsor

Istanbul Gelisim University

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)

15. januar 2026

Primær færdiggørelse (Faktiske)

29. januar 2026

Studieafslutning (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-20162-179

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