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

NCT07574580 | Enrolling By Invitation

• 1 other identifier: KartalHospital
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Burns

Keywords

Acute Burn Injury; Non-Invasive Vagus Nerve Stimulation; Inflammatory Response; Functional Recovery; Functional Independence Measure

Outcome Measures

Primary Outcomes (4)

• Change in C-Reactive Protein Level

  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

  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

  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

  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

Study Arms (2)

Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

EXPERIMENTAL

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.

Device: Non-Invasive Auricular Vagus Nerve Stimulation; Other: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy

Interventions

Non-Invasive Auricular Vagus Nerve Stimulation DEVICE

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.

Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

Conventional Physiotherapy OTHER

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.

Conventional Physiotherapy; Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Study Officials

• Sümeyye Akçay

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed before treatment and after completion of 10 treatment sessions.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)