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

NCT ID: NCT02454218

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

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 .

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Transcranial Direct Current Stimulation

The intensity of the asset is little perceived and painless.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Simulation Transcranial Current

Will receive only simulation.

Group Type: PLACEBO_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

tDCS -

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolnei M Caumo, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Porto Alegre Clinical Hospital

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Adriana F Silva, Msc

Role: CONTACT

adrisilva@hcpa.ufrgs.br

55 51 33598083

Facility Contacts

Adriana F Silva, Msc

Role: primary

adrisilva@hcpa.ufrgs.br

55 51 33598083

Other Identifiers

140231

Identifier Type: -

Identifier Source: org_study_id