Clinical trial NCT06170645: Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue
Official title: Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic fatigue
Transcutaneous vagal nerve stimulation (tVNS)
adapted physical activity (APA)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Fatigue evaluation assessed by autonomic nervous system activity
timeFrame: Month : 0; 3
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Month : 0; 6
measure: Medical Outcome Study Short Form questionnaire (MOS-SF 12)
timeFrame: Month : 0; 6
measure: Pittsburgh questionnaire
timeFrame: Month : 0; 6
measure: 6-minute walk test (6MWT)
timeFrame: Month : 0; 6
measure: Adult Physical Activity Questionnaire (APAQ)
timeFrame: Month : 0; 6
measure: Step count per day
timeFrame: Month : 0; 6
measure: Ratio of Low Frequency to High Frequency (LF/HF)
timeFrame: Month : 0; 6
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Centre Hospitalier de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: