Идёт набор NCT06170645

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

Без фазы С лечением Chronic Fatigue Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: APA program, Active transcutaneous VNS, Sham transcutaneous VNS.
Кому может быть актуально: Состояния в реестре: Chronic Fatigue Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое 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.
Другое 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.
Другое 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.

Первичные конечные точки

Fatigue evaluation assessed by autonomic nervous system activity [Срок оценки: Month : 0; 3]

Вторичные конечные точки (7)

Fatigue Severity Scale (FSS) [Срок оценки: Month : 0; 6]
Medical Outcome Study Short Form questionnaire (MOS-SF 12) [Срок оценки: Month : 0; 6]
Pittsburgh questionnaire [Срок оценки: Month : 0; 6]
6-minute walk test (6MWT) [Срок оценки: Month : 0; 6]
Adult Physical Activity Questionnaire (APAQ) [Срок оценки: Month : 0; 6]
Step count per day [Срок оценки: Month : 0; 6]
Ratio of Low Frequency to High Frequency (LF/HF) [Срок оценки: Month : 0; 6]

Критерии участия

Критерии включения

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