Transcranial direct current stimulation for fatigue in patients with Sjogren's syndrome: A randomized, double-blind pilot study

Ana Carolina Pereira Nunes Pinto; Sara Regina Piva; Aléxia Gabriela da Silva Vieira; Samantha Guerra Cabó Nunes Gomes; Aline Pereira Rocha; Daniela Regina Brandão Tavares; Márcia Valéria de Andrade Santana; Cristiane Carlesso; Adagmar Andriolo; Fania Cristina Santos; Felipe Fregni; Virgínia Fernandes Moça Trevisani

doi:10.1016/j.brs.2020.12.004

Transcranial direct current stimulation for fatigue in patients with Sjogren's syndrome: A randomized, double-blind pilot study

Brain Stimul. 2021 Jan-Feb;14(1):141-151. doi: 10.1016/j.brs.2020.12.004. Epub 2020 Dec 17.

Affiliations

¹ Evidence-Based Health Program, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil; Fulbright Scholar at University of Pittsburgh, PA, USA; Biological and Health Sciences Department, Universidade Federal Do Amapa (UNIFAP), AP, Brazil.
² Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh. Pittsburgh, PA, USA. Electronic address: spiva@pitt.edu.
³ Evidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, Brazil.
⁴ Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh. Pittsburgh, PA, USA.
⁵ Department of Medicine, EPM - UNIFESP, São Paulo, SP, Brazil.
⁶ Department of Geriatrics and Gerontology, EPM - UNIFESP, Brazil.
⁷ Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
⁸ Rheumatologist. Discipline of Emergency and Evidence-Based Medicine, EPM - UNIFESP, São Paulo, SP, Brazil.

PMID: 33340767
DOI: 10.1016/j.brs.2020.12.004

Abstract

Background: Transcranial direct-current stimulation (tDCS) has shown promise to decrease fatigue. However, it has never been examined in primary Sjogren Syndrome (pSS).

Objective: To assess the effect of a tDCS protocol on fatigue in patients with pSS.

Methods: This is a parallel, double-blind pilot study (NCT04119128). Women aged 18-65 years, with pSS, on stable pharmacological therapy, with complaints of fatigue for at least three months, and with scores >5 on Fatigue Severity Scale (FSS) were included. We randomized 36 participants to receive five consecutive or sham tDCS sessions, with an intensity of 2 mA, for 20 min/day.

Results: After five tDCS sessions, fatigue severity assessed by the FSS (primary outcome) demonstrated a mean group difference of -0.85 [95% confidence interval (CI) -1.57, -0.13; effect size 0.80] favouring the active group. The active group presented significantly greater reductions in fatigue as measured by the EULAR Sjögren's Syndrome Patient Reported Index after five tDCS sessions [mean group difference: 1.40; 95%CI -2.33, -0.48; effect size 1.04]. Although there were no between-group differences in the secondary outcomes of sleep, mood and anxiety, within-group comparisons evidenced a small but significant difference in the active group for pain and sleep. There were no significant cortisol changes. All reported adverse events were mild and transitory.

Conclusion: tDCS seems to be safe and reduce fatigue in pSS. A differential effect on pain and sleep may underlie its effects. Further studies are needed to optimise tDCS treatment strategies in pSS.

Keywords: Fatigue; Sjogren’s syndrome; Transcranial direct current stimulation.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Double-Blind Method
Fatigue / etiology
Fatigue / therapy
Female
Humans
Pilot Projects
Sjogren's Syndrome* / complications
Sjogren's Syndrome* / therapy
Transcranial Direct Current Stimulation*