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

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...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: Elsevier 2021-01-01
Series:Brain Stimulation
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1935861X20303077
_version_ 1818616175012085760
author 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
author_facet 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
author_sort Ana Carolina Pereira Nunes Pinto
collection DOAJ
description 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.
first_indexed 2024-12-16T16:45:37Z
format Article
id doaj.art-e3b692e203eb4863bccd59efda1dfeb9
institution Directory Open Access Journal
issn 1935-861X
language English
last_indexed 2024-12-16T16:45:37Z
publishDate 2021-01-01
publisher Elsevier
record_format Article
series Brain Stimulation
spelling doaj.art-e3b692e203eb4863bccd59efda1dfeb92022-12-21T22:24:12ZengElsevierBrain Stimulation1935-861X2021-01-01141141151Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot studyAna Carolina Pereira Nunes Pinto0Sara Regina Piva1Aléxia Gabriela da Silva Vieira2Samantha Guerra Cabó Nunes Gomes3Aline Pereira Rocha4Daniela Regina Brandão Tavares5Márcia Valéria de Andrade Santana6Cristiane Carlesso7Adagmar Andriolo8Fania Cristina Santos9Felipe Fregni10Virgínia Fernandes Moça Trevisani11Evidence-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, BrazilDepartment of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh. Pittsburgh, PA, USA; Corresponding author. Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, 100 Technology Dr, 15219, Pittsburgh, PA, USA.Evidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, BrazilEvidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, BrazilEvidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, BrazilEvidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, BrazilEvidence-Based Health Program, EPM, UNIFESP, São Paulo, SP, BrazilDepartment of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh. Pittsburgh, PA, USADepartment of Medicine, EPM - UNIFESP, São Paulo, SP, BrazilDepartment of Geriatrics and Gerontology, EPM - UNIFESP, BrazilSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USARheumatologist. Discipline of Emergency and Evidence-Based Medicine, EPM - UNIFESP, São Paulo, SP, BrazilBackground: 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.http://www.sciencedirect.com/science/article/pii/S1935861X20303077Sjogren’s syndromeFatigueTranscranial direct current stimulation
spellingShingle 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
Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
Brain Stimulation
Sjogren’s syndrome
Fatigue
Transcranial direct current stimulation
title Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
title_full Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
title_fullStr Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
title_full_unstemmed Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
title_short Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study
title_sort transcranial direct current stimulation for fatigue in patients with sjogren s syndrome a randomized double blind pilot study
topic Sjogren’s syndrome
Fatigue
Transcranial direct current stimulation
url http://www.sciencedirect.com/science/article/pii/S1935861X20303077
work_keys_str_mv AT anacarolinapereiranunespinto transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT sarareginapiva transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT alexiagabrieladasilvavieira transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT samanthaguerracabonunesgomes transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT alinepereirarocha transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT danielareginabrandaotavares transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT marciavaleriadeandradesantana transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT cristianecarlesso transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT adagmarandriolo transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT faniacristinasantos transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT felipefregni transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy
AT virginiafernandesmocatrevisani transcranialdirectcurrentstimulationforfatigueinpatientswithsjogrenssyndromearandomizeddoubleblindpilotstudy