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Recruiting NCT06170645

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

No phase Interventional Chronic Fatigue Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APA program, Active transcutaneous VNS, Sham transcutaneous VNS.
Who it may be relevant to
Registry conditions: Chronic Fatigue Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study

Overview

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.

Interventions

  • Other 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.
  • 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.
  • 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.

Primary outcome measures

  • Fatigue evaluation assessed by autonomic nervous system activity [Time frame: Month : 0; 3]
Secondary outcome measures (7)
  • Fatigue Severity Scale (FSS) [Time frame: Month : 0; 6]
  • Medical Outcome Study Short Form questionnaire (MOS-SF 12) [Time frame: Month : 0; 6]
  • Pittsburgh questionnaire [Time frame: Month : 0; 6]
  • 6-minute walk test (6MWT) [Time frame: Month : 0; 6]
  • Adult Physical Activity Questionnaire (APAQ) [Time frame: Month : 0; 6]
  • Step count per day [Time frame: Month : 0; 6]
  • Ratio of Low Frequency to High Frequency (LF/HF) [Time frame: Month : 0; 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06170645 · 23CH153 · 2023-A01792-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗