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

NCT06170645 | Recruiting

• 2 other identifiers: 23CH1532023-A01792-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic fatigue; Transcutaneous vagal nerve stimulation (tVNS); adapted physical activity (APA)

Outcome Measures

Primary Outcomes (1)

• Fatigue evaluation assessed by autonomic nervous system activity

  The root mean square of successive differences in heart rate (in milliseconds) will be measured from a nocturnal Holter ECG recording (Novacor, Paris, France) at the end of the 3-month APA and tVNS programme (month 3) and compared with pre-programme values (inclusion).

  Month : 0; 3

Secondary Outcomes (7)

• Fatigue Severity Scale (FSS)

  Month : 0; 6

• Medical Outcome Study Short Form questionnaire (MOS-SF 12)

  Month : 0; 6

• Pittsburgh questionnaire

  Month : 0; 6

• 6-minute walk test (6MWT)

  Month : 0; 6

• Adult Physical Activity Questionnaire (APAQ)

  Month : 0; 6

Study Arms (2)

Patients with active tVNS

EXPERIMENTAL

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

Other: APA program; Other: Active transcutaneous VNS

Patients with sham tVNS

SHAM COMPARATOR

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

Other: APA program; Other: Sham transcutaneous VNS

Interventions

APA program 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.

Patients with active tVNS; Patients with sham tVNS

Active transcutaneous VNS 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 active tVNS

Sham transcutaneous VNS 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.

Patients with sham tVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David HUPIN, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD

CONTACT

(0)4 77 82 84 13; david.hupin@chu-st-etienne.fr

Hélène RAINGARD, CRA

CONTACT

(0)4 77 12 08 26; helene.raingard@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: October 3, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)