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Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury

20. juli 2026 opdateret af: Buddhist Tzu Chi General Hospital
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury. Participants will undergo surgery to implant a system designed for cervical spinal cord EES. Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy. Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

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

  • Taiwan
      • Hualien City, Taiwan
        • Rekruttering
        • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
        • 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:

  • Age between 18 and 70 years.
  • Duration since spinal cord injury ranging from 1 to 10 years.
  • Spinal cord injury level at or above T4.
  • MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
  • Stable vital signs and no dependence on mechanical ventilation.
  • Stable neurological and psychological status, with no history of neurological deterioration within the past 6 months (e.g., acute worsening of motor or sensory function, new-onset seizures, acute changes in muscle tone, or other neurological symptoms). Participants must be conscious, able to understand, and comply with study instructions. Clinical neurological examinations and imaging findings (MRI or CT) should demonstrate no new abnormalities.
  • Willingness to participate in and comply with rehabilitation programs.
  • Participants who have completed spinal cord electrical stimulation implantation surgery and/or are currently undergoing conventional rehabilitation therapy.

Exclusion Criteria:

  • Patients with untreated fractures of the upper extremities.
  • Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
  • Patients with a history of other neurological diseases.
  • Patients with known allergy or hypersensitivity to silver (Ag).

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: Epidural electrical stimulation (EES)
Participants will undergo implantation of a 16-electrode epidural spinal cord array. Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural electrical stimulation.
Enhed: Epidural elektrisk stimulation (EES)
Forsøgspersonerne vil gennemgå en kirurgisk procedure for at implantere et system, der giver epidural elektrisk stimulation (EES) af den cervikale rygmarv. Efter operationen vil forsøgspersonerne gennemgå et struktureret fysisk rehabiliteringsprogram og elektrisk stimulering.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, with higher scores indicating greater independence in activities of daily living.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in neurological level of injury as determined by motor and sensory function assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized tool for assessing neurological impairment after spinal cord injury. It evaluates motor and sensory functions to determine the neurological level of injury and classify injury severity using the ASIA Impairment Scale (AIS), ranging from Grade A (complete injury) to Grade E (normal function).
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in hand dexterity as measured by the Box and Block Test (BBT).
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i livskvalitet (QOL) målt af World Health Organization Quality of Life (WHOQOL-BREF)
Tidsramme: Baseline; 1 - 4 - 7 - 13 - 19 - 25 måneder efter implantation
WHOQOL-BREF er et selvadministreret spørgeskema, der omfatter 26 spørgsmål om individets opfattelse af deres helbred og velvære i løbet af de foregående to uger. Svar på spørgsmål er på en Likert-skala fra 1-5, hvor 1 repræsenterer "uenig" eller "slet ikke" og 5 repræsenterer "helt enig" eller "ekstremt". , Jo højere score, jo bedre livskvalitet
Baseline; 1 - 4 - 7 - 13 - 19 - 25 måneder efter implantation
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in activities of daily living as measured by the Barthel Index (BI).
Tidsramme: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Barthel Index (BI) assesses functional independence in activities of daily living across 10 domains, including self-care, mobility, and continence. Scores range from 0 to 100, with higher scores indicating greater independence.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation

Samarbejdspartnere og efterforskere

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

Sponsor

Buddhist Tzu Chi General Hospital

Efterforskere

  • Ledende efterforsker: Sheng-Tzung Tsai, M.D., Ph.D, Hualien Tzu Chi General Hospital

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)

17. november 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. august 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB114-101-A
  • NSTC 114-2314-B-303-011 (Andet bevillings-/finansieringsnummer: National Science and Technology Council, R.O.C)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Rygmarvsskade (SCI)

Kliniske forsøg med Epidural elektrisk stimulation (EES)

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