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Non-invasive electrical brain stimulation in patients with vasculitis

Non-invasive brain neuromodulation in patients with primary systemic vasculitis: a randomized, double-blind, sham-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9n4z2hh
Enrollment
Unknown
Registered
2022-01-18
Start date
2021-11-01
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

Chronic fatigue

Interventions

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 determ
carried out over a period of four weeks (11 sessions). Sixty-two patients (n=62) with Takayasu's arteritis (TAK) will be selected, divided into two groups, sham (placebo) and intervention. At the sam
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Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Takayasu's Arteritis or Granulomatosis with Polyangiitis; diagnosis of chronic fatigue; older than 18 years; both sexes; read and understand the informed consent form.

Exclusion criteria

Exclusion criteria: Presence of neoplasm; critical/symptomatic aortic stenosis; Congestive heart failure; arrhythmias; ST-segment electrocardiographic changes; coronary heart disease; cardiac pacemaker users; users of cranial metal clips or prostheses; the presence of fibromyalgia; with severe walking impairment; pregnant or lactating patients; seizures or epilepsy; user of drugs acting on the central nervous system; skin lesion on the scalp.

Design outcomes

Primary

MeasureTime frame
Fatigue score reduction from the fatigue severity scale (FSS), 30% reduction.

Secondary

MeasureTime frame
Quality of life improvement assessed by the SF36 and HAQ questionnaire scores, 30% improvement.

Countries

Brazil

Contacts

Public ContactAlexandre Santos
alexandrestos@usp.br+55-011-995580730

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 13, 2026