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Unilateral and Bilateral taVNS in Fibromyalgia (taVNS-FMS)

5 mei 2026 bijgewerkt door: BUSENUR KARAGÖZ, Istanbul Gelisim University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Surgery or major trauma within the previous 6 months
  • Postmenopausal status
  • Pregnancy or lactation

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Unilateral taVNS
Participants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
Apparaat: taVNS
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Experimenteel: Bilateral taVNS
Participants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
Apparaat: taVNS
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Actieve vergelijker: Home Exercise Program
Participants followed a structured home-based exercise program for two weeks.
Gedragsmatig: Home Exercise Program
A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exercise performance (repetition count)
Tijdsspanne: Baseline (Week 0) and Week 2
Number of repetitions performed during exercise sessions to evaluate functional exercise performance.
Baseline (Week 0) and Week 2

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fibromyalgia Impact Questionnaire (FIQ) score
Tijdsspanne: Baseline (Week 0) and Week 2
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.
Baseline (Week 0) and Week 2
Beck Anxiety Inventory (BAI) score
Tijdsspanne: Baseline (Week 0) and Week 2
Change in Beck Anxiety Inventory (BAI) score (range: 0-63; higher scores indicate greater anxiety levels) to assess anxiety severity.
Baseline (Week 0) and Week 2
Beck Depression Inventory (BDI) score
Tijdsspanne: Baseline (Week 0) and Week 2
Change in Beck Depression Inventory (BDI) score (range: 0-63; higher scores indicate more severe depressive symptoms) to assess depression severity.
Baseline (Week 0) and Week 2
Pittsburgh Sleep Quality Index (PSQI) score
Tijdsspanne: Baseline (Week 0) and Week 2
Change in Pittsburgh Sleep Quality Index (PSQI) score (range: 0-21; higher scores indicate worse sleep quality) to assess sleep quality.
Baseline (Week 0) and Week 2
Heart Rate Variability (RMSSD)
Tijdsspanne: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in RMSSD (ms), reflecting parasympathetic activity.
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)
Tijdsspanne: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in pNN50 (%), representing parasympathetic modulation.
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)
Tijdsspanne: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in high-frequency (HF) power (ms²), reflecting parasympathetic nervous system activity.
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)
Tijdsspanne: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in low-frequency (LF) power (ms²), reflecting mixed sympathetic and parasympathetic activity.
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)
Tijdsspanne: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in LF/HF ratio (unitless), indicating autonomic balance between sympathetic and parasympathetic systems.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul Gelisim University

Medewerkers

Bahçeşehir University

Onderzoekers

  • Hoofdonderzoeker: Kerem KARAGÖZ, PhD, Bahçeşehir University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2022

Primaire voltooiing (Werkelijk)

20 juni 2023

Studie voltooiing (Werkelijk)

20 juni 2023

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FMS-taVNS-2022-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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