Using vagus nerve stimulation with exercise to help chronic fatigue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of transcutaneous vagus nerve stimulation (tVNS) as a complementary therapy to an adapted physical activity (APA) program for patients suffering from chronic fatigue due to fibromyalgia or long Covid. Participants will engage in a 4-6 week APA program while receiving either active or sham tVNS to assess its impact on fatigue reduction and recovery. The goal is to enhance adherence to exercise protocols that are typically more effective when sustained over longer periods. By combining these two interventions, the study aims to improve overall patient outcomes in managing chronic fatigue.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient over 18 years old
* Signature of informed consent
* Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)
* Persistent fatigue after an exercise rehabilitation program (FSS score \> 36)
* Physical inactivity, i.e. \<150 minutes per week of physical activity

Exclusion Criteria:

* Pre-existing atrial fibrillation,
* Left ventricular ejection fraction \<40%
* Severe heart failure
* Recent stroke or myocardial infarction (\<6 months)
* Unilateral or bilateral vagotomy
* Pregnancy or breastfeeding

Where it's running

• Centre Hospitalier de Saint-Etienne
  Saint-Etienne, France Recruiting

Study contacts

• Principal investigator: David HUPIN, MD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: David HUPIN, MD
• Email: david.hupin@chu-st-etienne.fr
• Phone: (0)4 77 82 84 13

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.