Unilateral and Bilateral taVNS in Fibromyalgia

NCT07577102 | Completed

• 1 other identifier: FMS-taVNS-2022-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fibromyalgia Syndrome

Keywords

Transcutaneous auricular vagus nerve stimulation; taVNS; Heart rate variability; Exercise performance; Autonomic nervous system; Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• Exercise performance (repetition count)

  Number of repetitions performed during exercise sessions to evaluate functional exercise performance.

  Baseline (Week 0) and Week 2

Secondary Outcomes (9)

• Fibromyalgia Impact Questionnaire (FIQ) score

  Baseline (Week 0) and Week 2

• Beck Anxiety Inventory (BAI) score

  Baseline (Week 0) and Week 2

• Beck Depression Inventory (BDI) score

  Baseline (Week 0) and Week 2

• Pittsburgh Sleep Quality Index (PSQI) score

  Baseline (Week 0) and Week 2

• Heart Rate Variability (RMSSD)

  Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement

Study Arms (3)

Unilateral taVNS

EXPERIMENTAL

Participants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.

Device: taVNS

Bilateral taVNS

EXPERIMENTAL

Participants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.

Device: taVNS

Home Exercise Program

ACTIVE COMPARATOR

Participants followed a structured home-based exercise program for two weeks.

Behavioral: Home Exercise Program

Interventions

taVNS DEVICE

Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.

Bilateral taVNS; Unilateral taVNS

Home Exercise Program BEHAVIORAL

A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.

Home Exercise Program

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Darülaceze Medical Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kerem KARAGÖZ, PhD

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial; no masking was applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start: January 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)