RecruitingNot ApplicableNCT06170645

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

60 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Fatigue Syndrome

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

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Interventions

OTHERAPA program

An APA program of 12 weeks, 2 sessions of 1h/week for mixed endurance, strengthening and stretching work. The program can be realized at home or in structure.

OTHERActive transcutaneous VNS

After each APA session, a 1h-tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.

OTHERSham transcutaneous VNS

After each APA session, a 1h-tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.