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Clinical Trials in Turkey / NCT07574580
Enrolling by invitation Not applicable

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

NCT07574580 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-05-11
Last updated
2026-07-07

Condition(s) studied

Acute Burns

Investigational drug(s) / intervention(s)

Non-Invasive Auricular Vagus Nerve StimulationConventional Physiotherapy

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kartal Dr. Lütfi Kırdar City Hospital Burn Unit Istanbul Kartal

More Fenerbahce University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07574580 on ClinicalTrials.gov ↗ ← All trials in Turkey