Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia

Phase 1

• Conditions: Fibromyalgia
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT02454218
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover.

Detailed Description

Check that the tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover. Patients answer the questionnaires in order to verify the Psychological Factors and Clinical. Will use the Impact of Fibromyalgia (QIF), Pittsburgh Sleep Questionnaire, Conditioned Pain Modulation (CPM), Beck Depression Scale II, Catastrophic Scale , Go noGo Test, Attention Network Task (ANT) to verify the ability attentional as well as to verify the Near-infrared spectroscopy (NIRS) brain oxygenation. They will be used before, during and after the intervention with tDCS. Intervention with tDCS or sham will be held in a single session. Expected results: It is expected that fibromyalgia patients undergoing tDCS present, after the intervention, improved attention capacity .

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-19
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Study First Posted: 2015-05-27
• Last Update Posted: 2015-05-27
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Female patients, literate, right-handed, 18 to 65 years of age, who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

Exclusion Criteria

• Pregnant women
• Contraindications to tDCS
• Metal implant in the brain
• History of alcohol or drug abuse in the last six months
• Suffer from severe depression (score> 30 on the Beck Depression Inventory)
• History of neurological disorders
• Unexplained fainting
• Self-reports of head injury or momentary loss of awareness
• Neurosurgery.
• Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation	The intensity of the asset is little perceived and painless.
Simulation Transcranial Current	Transcranial Direct Current Stimulation	Will receive only simulation.

Primary Outcome Measures

Name	Time	Method
Attention capacity after the intervention, assessed by the Attention Network Task	4 months

Trial Locations

Locations (1)

Porto Alegre Clinical Hospital; 🇧🇷 Porto Alegre, RS, Brazil