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

NCT ID: NCT06170645

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2026-08-31

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Patients with active tVNS

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

Group Type: EXPERIMENTAL

APA program

Intervention Type: OTHER

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.

Active transcutaneous VNS

Intervention Type: OTHER

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.

Patients with sham tVNS

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

Group Type: SHAM_COMPARATOR

APA program

Intervention Type: OTHER

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.

Sham transcutaneous VNS

Intervention Type: OTHER

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.

Interventions

APA 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.

Intervention Type: OTHER

Active 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.

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Centre Hospitalier de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David HUPIN, MD

Role: CONTACT

david.hupin@chu-st-etienne.fr

(0)4 77 82 84 13 ext. +33

Hélène RAINGARD, CRA

Role: CONTACT

helene.raingard@chu-st-etienne.fr

(0)4 77 12 08 26 ext. +33

Facility Contacts

David HUPIN, MD

Role: primary

Frédéric ROCHE, MD PhD

Role: backup

Other Identifiers

2023-A01792-43

Identifier Type: OTHER

Identifier Source: secondary_id

23CH153

Identifier Type: -

Identifier Source: org_study_id