Using vagus nerve stimulation with exercise to help chronic fatigue
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
This study is testing if using a special nerve stimulation along with a tailored exercise program can help people with chronic fatigue from fibromyalgia or long Covid feel better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06170645 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of fibromyalgia or long Covid who experience persistent fatigue despite previous exercise rehabilitation.
Not a fit: Patients with severe heart conditions, recent strokes, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce fatigue and improve recovery for patients with chronic fatigue syndrome.
How similar studies have performed: While the combination of tVNS and exercise is a novel approach, existing literature suggests that both interventions separately have shown promise in managing fatigue.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Saint-Etienne
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.