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Brain Modulation in patients with Autoimmune Diseases

Transcranial Direct Current Stimulation in patients with Systemic Autoimmune Diseases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6c6f8yv
Enrollment
Unknown
Registered
2023-02-28
Start date
2022-06-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

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
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.
E02.331.750

Sponsors

Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 52 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: Patients with: neoplasms; cardiac pacemaker users; users of cranial metal clips or prostheses; pregnant women; personal history of seizures or epilepsy; users of centrally-acting drugs or drugs that lower the seizure threshold; skin lesion on the scalp; in moderate, intense or very intense disease activity; using moderate to high doses of glucocorticoids; overlapping with systemic autoimmune rheumatic diseases other than antiphospholipid antibody syndrome

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes are not expected.—

Countries

Brazil

Contacts

Public ContactVanessa Andrade

Faculdade de Medicina da Universidade de São Paulo

vanessaposener@gmail.com+55-11-930046775

Outcome results

None listed

Source: REBEC (via WHO ICTRP)