Actively Recruiting
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-05-06
60
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Signed informed consent
- Confirmed diagnosis of fibromyalgia or long Covid with symptoms lasting more than 6 months after positive RT-PCR test
- Persistent fatigue after an exercise rehabilitation program with Fatigue Severity Scale score greater than 36
- Physical inactivity defined as less than 150 minutes of physical activity per week
You will not qualify if you...
- History of atrial fibrillation
- Left ventricular ejection fraction less than 40%
- Severe heart failure
- Stroke or myocardial infarction within the last 6 months
- Unilateral or bilateral vagotomy
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
D
David HUPIN, MD
CONTACT
H
Hélène RAINGARD, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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