NCT06170645 Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
| NCT ID | NCT06170645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Chronic Fatigue Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-03 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
David HUPIN, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT06170645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Fatigue Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06170645 currently recruiting?
Yes, NCT06170645 is actively recruiting participants. Contact the research team at david.hupin@chu-st-etienne.fr for enrollment information.
Where is the NCT06170645 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06170645 clinical trial?
NCT06170645 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is David HUPIN, MD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 60 participants.