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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
David HUPIN, MD
david.hupin@chu-st-etienne.fr
(0)4 77 82 84 13
Backup
Hélène RAINGARD, CRA
helene.raingard@chu-st-etienne.fr
(0)4 77 12 08 26
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2026-08
Participants
Target number of participants: 60
Treatments
Experimental: Patients with active tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
Sham_comparator: Patients with sham tVNS
Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov