NCT06170645Recruiting
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Dec 2023
- Start date
- 3 Oct 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06170645
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 3 Oct 2024 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe heart failure
- Recent stroke or myocardial infarction (\<6 months)
Lab values
- Left ventricular ejection fraction \<40%
Other
- Pre-existing atrial fibrillation,
- Unilateral or bilateral vagotomy
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.