Brain Modulation in patients with Autoimmune Diseases

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: E02.331.750 This is a two‐arm, double‐blind, randomized controlled clinical trial. Randomization will be performed through a random sequence controlled by a third unblinded evaluator, who will not participate in the intervention sessions. The session will consist of exercise on a treadmill performed concomitantly with transcranial electrical stimulation by direct current or Sham, according to randomization, the intensity will be determined by the 6‐minute walk physical test. The volume of the aerobic exercise session will be 30 minutes, consisting of 5 minutes of warm‐up, 20 minutes of exercise between the thresholds (La and PCRe) and finally 5 minutes of cool‐down; carried out in a period of 5 days (5 sessions). 128 patients (n=128) with systemic lupus erythematosus (SLE) will be selected, divided into two groups, Sham (placebo) and intervention. CONDITION: C20.111 Fatigue Syndrome, Chronic; Chronic pain; Lupus Erythematosus, Systemic PRIMARY OUTCOME: It is expected to find a reduction in the fatigue score of 30% after 5 sessions of neuromodulation; we will evaluate the outcome from the fatigue severity scale (FSS) applied before and after the end of the sessions. SECONDARY OUTCOME: Secondary outcomes are not expected. INCLUSION CRITERIA: Female patients with the defined systemic autoimmune disease Systemic Lupus Erythematosus (all meet the 2019 EULAR/ACR classification criteria); in regular outpatient follow‐up; having a picture of fatigue or significant pain; presenting the Severity of Fatigue Scale (EGF) greater than or equal to 36 points; relatively stable use of medication in the last month; able to understand and complete the Free and Informed Consent Form (TCLE)
Epistemonikos ID: 2856694ed14da9721ccb376564a6d14021836962
First added on: Feb 20, 2024