tDCS in Post-Acute COVID-19 Patients With SARDs

Официальное название

Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases

Обзор

Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains. The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.

Подробное описание

Currently, there are no studies evaluating the tDCS technique in ARD patients with post-acute COVID-19; therefore, the main objective of the present study is to evaluate the safety and efficacy of the application of acute tDCS in these specific patients.

Вмешательства

• Устройство Transcranial direct current stimulation
  tDCS: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of dir

Первичные конечные точки

• Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: [Time Frame: After 30 minutes of transcranial stimulation.]]
• Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: [Time Frame: After 5 sessions of transcranial stimulation.]]
• Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: [Time Frame: After 30 days of transcranial stimulation.]]
• Frequency of treatment-emergent adverse events [safety and tolerability] [Срок оценки: [Time Frame: After 60 days of transcranial stimulation.]]

Вторичные конечные точки (1)

• Health Assessment Questionnaire (HAQ) [Срок оценки: [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]]

Критерии участия

Критерии включения

• Patients with well-defined ARDs (rheumatoid arthritis, sclerosis systemic, Sjögren syndrome, spondyloarthritis, systemic lupus erythematosus, systemic vasculitis, and systemic autoimmune myopathies)
• Fatigue or general pains.

Критерии исключения

• Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Samuel K Shinjo — São Paulo

Идентификаторы

NCT: NCT04890483 · MYO-HCFMUSP-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗