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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Burns
• Intervention / Treatment: Device: Non-Invasive Auricular Vagus Nerve Stimulation; Other: Conventional Physiotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fenerbahce University
• Investigators: Principal Investigator: Sümeyye Akçay, Fenerbahçe University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Inflammatory Response; Functional Recovery; Functional Independence Measure; Non-Invasive Vagus Nerve Stimulation; Acute Burn Injury
• Other Study ID Numbers: KartalHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No