tDCS for Fatigue in Sjogren's Syndrome

Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial

Sponsoren

Hauptsponsor: Federal University of São Paulo

Mitarbeiter: University of Pittsburgh
Universidade Federal do Amapá

Quelle Federal University of São Paulo
Kurze Zusammenfassung

Sjogren's Syndrome (SS) is an autoimune disease of unknown etiology characterized by lymphocytic infiltration of the exocrine glands and other organs. patients usually presents with xerophthalmia, xerostomia, fatigue and other symptoms. Fatigue has often been reported as the biggest problem and the most difficult symptom patients have to deal with. Fatigue management in pSS is difficult. However, in other diseases such as Parkinson disease, post-polio syndrome and multiple sclerosis the use of Transcranial Direct Current Stimulation (tDCS) has recently been studied and has shown effectiveness. The overarching objective of this study is to examine the effect of a tDCS protocol in patients with pSS.

Gesamtstatus Completed
Anfangsdatum June 3, 2019
Fertigstellungstermin April 1, 2020
Primäres Abschlussdatum April 1, 2020
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change in Fatigue Change in fatigue from baseline to 15 days after the end of stimulation.
Sekundäres Ergebnis
Messen Zeitfenster
Change in Profile of Fatigue Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation
Change in Symptoms severity Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation
Change in Quality of Life Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation
Change in Patient Global Assessment Will be measured after the 1st, 5th day of stimulation, 15 days after the end of stimulation and 30 days after the end of stimulation.
Change in Adverse Events Will be measured up to 30 days after the end of stimulation.
Einschreibung 36
Bedingung
Intervention

Interventionsart: Device

Interventionsname: Active Transcranial Direct Current Stimulation

Beschreibung: Subjects will undergo 5 sessions of tDCS of up to 2mA, at 20 minutes per session, 1x per day. During active stimulation, the current will be active for the full 20 minutes.

Armgruppenetikett: Active tDCS

Interventionsart: Device

Interventionsname: Sham Transcranial Direct Current Stimulation

Beschreibung: Subjects will undergo 5 sessions of tDCS, at 20 minutes per session, 1x per day. For sham tDCS, electrodes will be placed the same way as in the intervention group, for 20 minutes. However, the stimulator will deliver 2mA of current for only 30s. The current will not be active for the rest of the 20 minutes.

Armgruppenetikett: Sham tDCS

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Women

- Age between 18 and 65 years old;

- Diagnosis of primary Sjogren's Syndrome according to American-European Criteria;

- Stable pharmacological therapy for at least 3 months;

- Complaints of fatigue as assessed by Fatigue Severity Scale (FSS>5).

- Complaints of fatigue for more than 3 months.

Exclusion Criteria:

- Heart, coronary, respiratory, renal, or hepatic uncompensated insufficiencies;

- Uncompensated systemic arterial hypertension;

- Unable to answer the questionnaires.

- Severe depression (with a score > 30 in the Beck Depression Inventory)

- History of epilepsy or syncope

- Implanted brain metallic devices

- Established cognitive impairment

- Traumatic brain injury with residual neurological deficits

Geschlecht: Female

Mindestalter: 18 Years

Maximales Alter: 65 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Ana Pinto, MSc Principal Investigator Federal University of Amapa/Federal University of Sao Paulo
Ort
Einrichtung: FUSaoPaulo
Standort Länder

Brazil

Überprüfungsdatum

May 2020

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Federal University of São Paulo

Vollständiger Name des Ermittlers: Ana Carolina Pereira Nunes Pinto

Ermittlertitel: MSc

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Active tDCS

Art: Active Comparator

Beschreibung: Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.

Etikette: Sham tDCS

Art: Sham Comparator

Beschreibung: Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.

Patientendaten Yes
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov