Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue (PAF-tVNS)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Chronic Fatigue Syndrome

Treatments: Other: Sham transcutaneous VNS; Other: APA program; Other: Active transcutaneous VNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06170645

23CH153

2023-A01792-43 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Patients with active tVNS

Experimental group

Description:

Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.

Treatment:

Other: Active transcutaneous VNS

Other: APA program

Patients with sham tVNS

Sham Comparator group

Description:

Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.

Treatment:

Other: APA program

Other: Sham transcutaneous VNS