Status:
RECRUITING
Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Transcutaneous Vagus Nerve Stimulation on Fibromyalgia
Eligibility:
FEMALE
18-79 years
Phase:
NA
Brief Summary
Stimulation of the vagus nerve, a parasympathetic nerve that controls the digestive, the vascular and immune systems, produces pain relief in various clinical conditions. Transmission via vagal affere...
Detailed Description
Fibromyalgia is a multidimensional disease, as many factors contribute to its development (biological, genetic, psychosocial). As a result, it demands a multifaceted approach, from patient education t...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women between 18-79 years old
- Women diagnosed with Fibromyalgia according to the ACR 2016 Revised Classification Criteria
- Moderate to high pain intensity according to analog pain scales (above 4 points over 10), for more than 6 months
- Cognitive function sufficient to understand the experiments and follow instructions
- Ability to read and understand all information on the device display.
- Ability to adjust the strength of the stimulation or give feedback regarding their response to the device (feeling tingling/pulsating/pain).
- Ability to comply with the recommended therapy regiment of 30 min per day.
- The ear electrode needs to fit the patient.
- Patients with physical or mental disabilities
- The patient must be able to use the device by themselves or
- The patients' caretaker can operate the device on the patient. In this case the patient --must still be able to give feedback regarding their response to the device
- Exclusion Criteria
- Cardiac arrhythmias
- Pregnancy
- Serious mental disorder (dipolar disorder, schizophrenia etc.)
- Prior injury to the vagus nerve
- Individuals with scar tissue that may interfere with the stimulation
- Presence of an electrically or magnetically activated implant
Exclusion
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06912334
Start Date
October 15 2024
End Date
June 1 2026
Last Update
April 4 2025
Active Locations (1)
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1
Aretaieion University Hospital
Athens, Greece, Greece, 11523