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New treatment option for Transcutaneous Vagus Nerve Stimulation on Fibromyalgia
Official title Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06912334
What this study is testing
- What it's testing
- 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 afferents to the nucleus of the solitary tract has been proposed as the primary physiological mechanism that reduces pain intensity following vagal stimulation.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79, women only
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.