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

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Porto Alegre Clinical Hospital
      • Contact: Adriana F Silva, Msc; Phone Number: 55 51 33598083; Email: adrisilva@hcpa.ufrgs.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcranial Direct Current Stimulation; The intensity of the asset is little perceived and painless.	Device: Transcranial Direct Current Stimulation; The intervention session with tDCS lasts for 20 minutes. tDCS uses rubber electrodes that are within sponges that are moistened with saline. These electrodes are placed on the participant's head. Through these electrodes will pass a weak electrical current that can at most cause mild itching at the site where the electrode is positioned. The generated electric current is equivalent to a small common battery that we use to run toys or radios. The procedure does not require that the patient be subjected to shocks, cuts or surgery. The participant will receive active tDCS or placebo, but receive both types of intervention during the performance of the two sessions.; Other Names: tDCS -
Placebo Comparator: Simulation Transcranial Current; Will receive only simulation.	Device: Transcranial Direct Current Stimulation; The intervention session with tDCS lasts for 20 minutes. tDCS uses rubber electrodes that are within sponges that are moistened with saline. These electrodes are placed on the participant's head. Through these electrodes will pass a weak electrical current that can at most cause mild itching at the site where the electrode is positioned. The generated electric current is equivalent to a small common battery that we use to run toys or radios. The procedure does not require that the patient be subjected to shocks, cuts or surgery. The participant will receive active tDCS or placebo, but receive both types of intervention during the performance of the two sessions.; Other Names: tDCS -

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attention capacity after the intervention, assessed by the Attention Network Task	4 months

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Wolnei M Caumo, M.D., PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Fibromyalgia; Transcranial direct current stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 140231