Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment that combines a type of therapy called transcutaneous vagal nerve stimulation (tVNS) with exercise programs for people suffering from Chronic Fatigue Syndrome, specifically those with fibromyalgia or long Covid. The goal is to see if this combination can help reduce fatigue and improve recovery for patients who find it hard to stick to traditional exercise programs, which usually last 8-12 weeks and require regular sessions. By using this device alongside adapted physical activity, researchers hope to enhance the benefits of exercise and make it easier for patients to feel better.

To participate in the trial, individuals need to be over 18 years old, have a confirmed diagnosis of fibromyalgia or long Covid, and experience ongoing fatigue even after trying an exercise program. They also should not be very active, doing less than 150 minutes of exercise per week. Participants can expect to engage in a structured exercise program while using the tVNS device, which may help them overcome their fatigue more effectively. It's important to note that there are some health conditions that would exclude someone from participating, such as heart problems or recent serious health issues.

Gender

ALL

Eligibility 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