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

Last updated: April 7, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Fatigue Syndrome

Pain (Pediatric)

Fibromyalgia

Treatment

APA program

Sham transcutaneous VNS

Active transcutaneous VNS

Clinical Study ID

NCT06170645
23CH153
2023-A01792-43
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patient over 18 years old

  • Signature of informed consent

  • Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistentsymptoms 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

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

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: APA program
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Centre Hospitalier de Saint-Etienne

    Saint-Etienne, 42055
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.