Fibromyalgia SyndrometaVNS-FMSNCT07577102
Unilateral and Bilateral taVNS in Fibromyalgia
A study testing taVNS and Home Exercise Program in people with Fibromyalgia Syndrome, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- taVNS and Home Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Were between 18 and 45 years of age
- Were diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria
- -- Stable clinical condition
- Ability to understand and follow study procedures
- Willingness to participate and provide informed consent
Who cannot join
- A history of malignancy
- Cardiopulmonary diseases contraindicating exercise
- Limb loss
- Ear infections and implants, implanted electronic devices
- Systemic diseases (hematological, endocrine, rheumatological, renal, cardiovascular, gastrointestinal, neurological, or autoimmune diseases)
- Active infection
Show all 9Show fewer
- Surgery or major trauma within the previous 6 months
- Postmenopausal status
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Unilateral and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Function and Exercise Performance in Fibromyalgia
This randomized controlled trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia syndrome (FMS).
Participants diagnosed with fibromyalgia were randomly assigned to one of three groups: unilateral taVNS, bilateral taVNS, or a home exercise program. The intervention period lasted two weeks and included ten treatment sessions. Clinical outcomes were assessed using validated scales including the Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Autonomic function was evaluated using heart rate variability (HRV) parameters, and exercise performance was assessed based on repetition capacity.
The study aimed to determine whether bilateral stimulation provides additional benefits compared to unilateral stimulation and exercise alone. The findings may contribute to understanding the role of neuromodulation strategies in improving autonomic regulation, symptom severity, and functional performance in individuals with fibromyalgia.
Read the detailed description
Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms, often associated with autonomic nervous system dysfunction. Reduced heart rate variability (HRV) and increased sympathetic activity are commonly observed in individuals with FMS, contributing to impaired exercise tolerance and reduced quality of life.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that targets the auricular branch of the vagus nerve and has been shown to influence autonomic regulation and central pain processing. However, evidence regarding its effects on exercise performance and the comparative efficacy of unilateral versus bilateral stimulation remains limited.
This study was designed as a randomized controlled trial including individuals diagnosed with fibromyalgia. Participants were allocated into three groups: unilateral taVNS, bilateral taVNS, and a home exercise program. The interventions were applied over a two-week period consisting of ten sessions. The taVNS intervention was administered via auricular stimulation targeting vagal afferents, while the exercise group followed a structured home-based program.
Outcome measures included clinical symptom scales (FIQ, BAI, BDI, PSQI), autonomic nervous system parameters derived from HRV analysis (including RMSSD, pNN50, LF, HF, and LF/HF ratio), and exercise performance assessed through repetition capacity. Assessments were conducted before and after the intervention period.
The primary objective was to compare the effects of unilateral and bilateral taVNS on autonomic function and exercise performance, and to evaluate whether combining neuromodulation with exercise provides additional clinical benefits in individuals with fibromyalgia. The results of this study may help inform rehabilitation strategies integrating neuromodulation and exercise-based interventions.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- taVNS, Home Exercise Program
- Keywords
- Transcutaneous auricular vagus nerve stimulation, taVNS, Heart rate variability, Exercise performance, Autonomic nervous system, Fibromyalgia Syndrome
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Home Exercise ProgramBehavioural
A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral taVNS | Experimental | Participants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period. Receives: Device: taVNS |
| Bilateral taVNS | Experimental | Participants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period. Receives: Device: taVNS |
| Home Exercise Program | Active comparator | Participants followed a structured home-based exercise program for two weeks. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance (repetition count)
Number of repetitions performed during exercise sessions to evaluate functional exercise performance.
Measured: Baseline (Week 0) and Week 2
Secondary outcomes (9)
Fibromyalgia Impact Questionnaire (FIQ) score
Change in Fibromyalgia Impact Questionnaire (FIQ) score (range: 0-100; higher scores indicate worse disease severity and functional impairment) to assess disease severity and functional status in patients with fibromyalgia.
Measured: Baseline (Week 0) and Week 2
Beck Anxiety Inventory (BAI) score
Change in Beck Anxiety Inventory (BAI) score (range: 0-63; higher scores indicate greater anxiety levels) to assess anxiety severity.
Measured: Baseline (Week 0) and Week 2
Beck Depression Inventory (BDI) score
Change in Beck Depression Inventory (BDI) score (range: 0-63; higher scores indicate more severe depressive symptoms) to assess depression severity.
Measured: Baseline (Week 0) and Week 2
Pittsburgh Sleep Quality Index (PSQI) score
Change in Pittsburgh Sleep Quality Index (PSQI) score (range: 0-21; higher scores indicate worse sleep quality) to assess sleep quality.
Measured: Baseline (Week 0) and Week 2
Heart Rate Variability (RMSSD)
Change in RMSSD (ms), reflecting parasympathetic activity.
Measured: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (pNN50)
Change in pNN50 (%), representing parasympathetic modulation.
Measured: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (HF power)
Change in high-frequency (HF) power (ms²), reflecting parasympathetic nervous system activity.
Measured: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF power)
Change in low-frequency (LF) power (ms²), reflecting mixed sympathetic and parasympathetic activity.
Measured: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF/HF ratio)
Change in LF/HF ratio (unitless), indicating autonomic balance between sympathetic and parasympathetic systems.
Measured: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jan 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- 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 were randomly assigned to one of three parallel groups: unilateral transcutaneous auricular vagus nerve stimulation (taVNS), bilateral taVNS, or a home exercise program. Each participant remained in their assigned group throughout the intervention period, and outcomes were compared between groups.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, BUSENUR KARAGÖZ, Istanbul Gelisim University
- Investigators
- Kerem KARAGÖZ, PhD, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577102
- Sponsor's protocol ID
- FMS-taVNS-2022-01
- Acronym
- taVNS-FMS
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves a limited sample size, and participants did not consent to data sharing beyond the scope of this research.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Unilateral and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Function and Exercise Performance in Fibromyalgia
- ClinicalTrials.gov ID
- NCT07577102
- Acronym / sponsor ID
- taVNS-FMS / FMS-taVNS-2022-01
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Transcutaneous auricular vagus nerve stimulation, taVNS, Heart rate variability, Exercise performance, Autonomic nervous system, Fibromyalgia Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 11 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 trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia syndrome (FMS).
Participants diagnosed with fibromyalgia were randomly assigned to one of three groups: unilateral taVNS, bilateral taVNS, or a home exercise program. The intervention period lasted two weeks and included ten treatment sessions. Clinical outcomes were assessed using validated scales including the Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Autonomic function was evaluated using heart rate variability (HRV) parameters, and exercise performance was assessed based on repetition capacity.
The study aimed to determine whether bilateral stimulation provides additional benefits compared to unilateral stimulation and exercise alone. The findings may contribute to understanding the role of neuromodulation strategies in improving autonomic regulation, symptom severity, and functional performance in individuals with fibromyalgia.
Detailed description
Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms, often associated with autonomic nervous system dysfunction. Reduced heart rate variability (HRV) and increased sympathetic activity are commonly observed in individuals with FMS, contributing to impaired exercise tolerance and reduced quality of life.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that targets the auricular branch of the vagus nerve and has been shown to influence autonomic regulation and central pain processing. However, evidence regarding its effects on exercise performance and the comparative efficacy of unilateral versus bilateral stimulation remains limited.
This study was designed as a randomized controlled trial including individuals diagnosed with fibromyalgia. Participants were allocated into three groups: unilateral taVNS, bilateral taVNS, and a home exercise program. The interventions were applied over a two-week period consisting of ten sessions. The taVNS intervention was administered via auricular stimulation targeting vagal afferents, while the exercise group followed a structured home-based program.
Outcome measures included clinical symptom scales (FIQ, BAI, BDI, PSQI), autonomic nervous system parameters derived from HRV analysis (including RMSSD, pNN50, LF, HF, and LF/HF ratio), and exercise performance assessed through repetition capacity. Assessments were conducted before and after the intervention period.
The primary objective was to compare the effects of unilateral and bilateral taVNS on autonomic function and exercise performance, and to evaluate whether combining neuromodulation with exercise provides additional clinical benefits in individuals with fibromyalgia. The results of this study may help inform rehabilitation strategies integrating neuromodulation and exercise-based interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups: unilateral transcutaneous auricular vagus nerve stimulation (taVNS), bilateral taVNS, or a home exercise program. Each participant remained in their assigned group throughout the intervention period, and outcomes were compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Unilateral taVNS | Experimental | Device: taVNSParticipants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period. |
| Bilateral taVNS | Experimental | Device: taVNSParticipants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period. |
| Home Exercise Program | Active comparator | Behavioral: Home Exercise ProgramParticipants followed a structured home-based exercise program for two weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Were between 18 and 45 years of age
- Were diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria
- -- Stable clinical condition
- Ability to understand and follow study procedures
- Willingness to participate and provide informed consent
Key exclusion criteria (9 listed)
- A history of malignancy
- Cardiopulmonary diseases contraindicating exercise
- Limb loss
- Ear infections and implants, implanted electronic devices
- Systemic diseases (hematological, endocrine, rheumatological, renal, cardiovascular, gastrointestinal, neurological, or autoimmune diseases)
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 |
|---|---|---|
| taVNSTranscutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes. | Device | Bilateral taVNS, Unilateral taVNS |
| Home Exercise ProgramA structured home-based exercise program including strengthening and mobility exercises performed over a two-week period. | Behavioural | Home Exercise Program |
Primary outcome
Exercise performance (repetition count)
Time frame: Baseline (Week 0) and Week 2
Number of repetitions performed during exercise sessions to evaluate functional exercise performance.
9 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline (Week 0) and Week 2
Beck Anxiety Inventory (BAI) score
Time frame: Baseline (Week 0) and Week 2
Beck Depression Inventory (BDI) score
Time frame: Baseline (Week 0) and Week 2
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline (Week 0) and Week 2
Heart Rate Variability (RMSSD)
Time frame: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (pNN50)
Time frame: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (HF power)
Time frame: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF power)
Time frame: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF/HF ratio)
Time frame: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves a limited sample size, and participants did not consent to data sharing beyond the scope of this research.
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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. This study is not recruiting at the moment.
Kerem KARAGÖZ, PhD principal investigator
Bahçeşehir 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 taVNS and Home Exercise Program in people with Fibromyalgia Syndrome, run by Istanbul Gelisim 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise performance (repetition count) (time frame: Baseline (Week 0) and Week 2). 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 11 May 2026.