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Non-Invasive Vagus Nerve Stimulation in Patients With Acute Burn Injuries

4. maj 2026 opdateret af: Sümeyye Akçay, Fenerbahce University

The Effects of Non-Invasive Vagus Nerve Stimulation on Inflammatory Response and Functional Recovery in Patients With Acute Burn Injuries

This randomized controlled study will investigate the effects of non-invasive vagus nerve stimulation on inflammatory response and functional recovery in adults with acute burn injuries. Participants will be adults aged 18 to 65 years with second- or third-degree burns involving 5% to 30% of total body surface area and who are enrolled within the first 72 hours after hospitalization.

Participants will be randomly assigned to one of two groups. The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only. The stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions.

The main outcomes will be inflammatory response, assessed by C-reactive protein levels, and functional recovery, assessed by the Functional Independence Measure. Assessments will be performed before the intervention and after completion of the 10 treatment sessions.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Burn injuries may trigger a systemic inflammatory response and lead to impaired functional recovery. Non-invasive auricular vagus nerve stimulation may modulate autonomic and inflammatory pathways and may support recovery in patients with acute burn injuries.

This randomized controlled study will be conducted in adults with acute second- or third-degree burn injuries involving 5% to 30% of total body surface area. Eligible participants will be enrolled within the first 72 hours after hospitalization and randomly assigned to an intervention group or a control group.

The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. Stimulation will be delivered using surface electrodes placed on the auricular region of the ear. Each session will last 20 minutes, and the intervention will be administered for a total of 10 sessions. The control group will receive conventional physiotherapy only. Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.

Outcome assessments will be performed before treatment and after completion of the 10 treatment sessions. Inflammatory response will be evaluated using C-reactive protein levels obtained from routine blood test records. Functional recovery will be evaluated using the Functional Independence Measure, joint range of motion, and muscle strength assessments.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
    • Kartal
      • Istanbul, Kartal, Tyrkiet (Türkiye), 34865
        • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

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:

  • Aged 18 to 65 years
  • Diagnosed with second- or third-degree burn injury involving 5% to 30% of total body surface area
  • Enrolled within the first 72 hours after hospitalization due to burn injury
  • Stable vital signs and general clinical condition suitable for the intervention
  • Able to read and understand Turkish and communicate adequately
  • Provided written informed consent

Exclusion Criteria:

  • Severe burn injury in the head and neck region preventing application of the device to the auricular vagus nerve area
  • Chronic pulmonary and/or cardiac disease
  • Heart rate below 60 beats per minute
  • History of epilepsy, severe psychiatric disease, or neurological disorder
  • Presence of a cardiac pacemaker or implantable electronic device
  • Autoimmune or chronic systemic inflammatory disease
  • Cognitive impairment preventing adherence to the study protocol

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy
Participants in this group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. Stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions. Conventional physiotherapy will be provided according to individual clinical needs.
Enhed: Non-Invasive Auricular Vagus Nerve Stimulation
Non-invasive auricular vagus nerve stimulation will be applied using surface electrodes placed on the auricular region of the ear. Each session will last 20 minutes, and the intervention will be administered for a total of 10 sessions. Stimulation intensity will be adjusted according to the participant's sensory threshold and tolerance.
Andet: Conventional Physiotherapy
Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.
Aktiv komparator: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only. Physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and active range of motion exercises.
Andet: Conventional Physiotherapy
Conventional physiotherapy will be planned according to individual clinical needs and may include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor activities, active range of motion exercises, and neurodevelopmental treatment approaches.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in C-Reactive Protein Level
Tidsramme: Baseline and Week 4, immediately after completion of the 10th treatment session
C-reactive protein level will be used to assess systemic inflammatory response. CRP values will be obtained from routine blood test records and recorded in mg/L.
Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Functional Independence Measure Score
Tidsramme: Baseline and Week 4, immediately after completion of the 10th treatment session
Functional recovery will be assessed using the Functional Independence Measure. The scale evaluates motor and cognitive independence in activities of daily living. Total scores range from 18 to 126, with higher scores indicating greater functional independence.
Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Joint Range of Motion
Tidsramme: Baseline and Week 4, immediately after completion of the 10th treatment session
Joint range of motion of joints affected by burn injury will be assessed using a universal goniometer. Measurements will be recorded in degrees.
Baseline and Week 4, immediately after completion of the 10th treatment session
Change in Muscle Strength
Tidsramme: Baseline and Week 4, immediately after completion of the 10th treatment session
Muscle strength will be assessed using manual muscle testing. Relevant muscle groups affected by burn injury will be evaluated, with higher grades indicating greater muscle strength.
Baseline and Week 4, immediately after completion of the 10th treatment session

Samarbejdspartnere og efterforskere

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

Sponsor

Fenerbahce University

Efterforskere

  • Ledende efterforsker: Sümeyye Akçay, Fenerbahçe 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 (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • KartalHospital

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the dataset may contain sensitive clinical information related to burn injuries and hospitalization. Data will be used only by the study investigators for the purposes approved by the ethics committee, and confidentiality of participants will be maintained.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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