Acute BurnsNCT07574580
Non-Invasive Vagus Nerve Stimulation in Patients With Acute Burn Injuries
A study testing Non-Invasive Auricular Vagus Nerve Stimulation and Conventional Physiotherapy in people with Acute Burns, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Burns
- What is being tested?
- Non-Invasive Auricular Vagus Nerve Stimulation and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
Istanbul, Kartal, 34865
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Burns
- Being tested
- Non-Invasive Auricular Vagus Nerve Stimulation, Conventional Physiotherapy
- Keywords
- Acute Burn Injury, Non-Invasive Vagus Nerve Stimulation, Inflammatory Response, Functional Recovery, Functional Independence Measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Auricular Vagus Nerve StimulationDevice
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 PhysiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4, immediately after completion of the 10th treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start11 May 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BurnsStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574580
- Sponsor's protocol ID
- KartalHospital
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non-Invasive Vagus Nerve Stimulation on Inflammatory Response and Functional Recovery in Patients With Acute Burn Injuries
- ClinicalTrials.gov ID
- NCT07574580
- Acronym / sponsor ID
- KartalHospital
- Conditions
- Acute Burns
- Keywords
- Acute Burn Injury, Non-Invasive Vagus Nerve Stimulation, Inflammatory Response, Functional Recovery, Functional Independence Measure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy | Experimental | Device: Non-Invasive Auricular Vagus Nerve Stimulation, Other: Conventional PhysiotherapyParticipants 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. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Auricular Vagus Nerve StimulationNon-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. | Device | Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy |
| Conventional PhysiotherapyConventional 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. | Other | Conventional Physiotherapy, Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy |
Primary outcome
Change in C-Reactive Protein Level
Time frame: 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.
Change in Functional Independence Measure Score
Time frame: 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.
Change in Joint Range of Motion
Time frame: 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.
Change in Muscle Strength
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyye Akçay principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Auricular Vagus Nerve Stimulation and Conventional Physiotherapy in people with Acute Burns, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-Reactive Protein Level (time frame: Baseline and Week 4, immediately after completion of the 10th treatment session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.