Trial record 41 of 126 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02454218
First received: January 19, 2015
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Device: Transcranial Direct Current Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Attention capacity after the intervention, assessed by the Attention Network Task [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: tDCS -

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02454218

Contacts
Contact: Adriana F Silva, Msc 55 51 33598083 adrisilva@hcpa.ufrgs.br

Locations
Brazil
Porto Alegre Clinical Hospital Recruiting
Porto Alegre, RS, Brazil
Contact: Adriana F Silva, Msc    55 51 33598083    adrisilva@hcpa.ufrgs.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Wolnei M Caumo, M.D., PhD Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02454218     History of Changes
Other Study ID Numbers: 140231
Study First Received: January 19, 2015
Last Updated: May 21, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Fibromyalgia
Transcranial direct current stimulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 30, 2015