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

Chronic Fatigue Syndrome Clinical Trial

— PAF-tVNS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06170645
• Other study ID #: 23CH153
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: David HUPIN, MD
• Phone: (0)4 77 82 84 13
• Email: david.hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatigue Severity Scale (FSS)	Subjective fatigue assessed by FSS, score from 9 to 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.	Month : 0; 6
Secondary	Medical Outcome Study Short Form questionnaire (MOS-SF 12)	Quality of life assessed by the MOS-SF 12 questionnaire , score from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.	Month : 0; 6
Secondary	Pittsburgh questionnaire	Quality of sleep assessed by Pittsburgh questionnaire (score 0 to 21). The 7 components of the score add up to give an overall score ranging from give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.	Month : 0; 6
Secondary	6-minute walk test (6MWT)	Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.	Month : 0; 6
Secondary	Adult Physical Activity Questionnaire (APAQ)	Physical activity assessed by the APAQ, time spend to physical activity in hours/day.	Month : 0; 6
Secondary	Step count per day	Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.	Month : 0; 6
Secondary	Ratio of Low Frequency to High Frequency (LF/HF)	The autonomic balance (sympathetic/parasympathetic) will be analysed by measuring the LF/HF ratio on the basis of a nocturnal Holter ECG recording (Novacor, Paris, France).	Month : 0; 6