Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 27, 2015
May 1, 2015
6 months
January 19, 2015
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attention capacity after the intervention, assessed by the Attention Network Task
4 months
Study Arms (2)
Transcranial Direct Current Stimulation
ACTIVE COMPARATORThe intensity of the asset is little perceived and painless.
Simulation Transcranial Current
PLACEBO COMPARATORWill receive only simulation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female patients, literate, right-handed, 18 to 65 years of age, who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Porto Alegre Clinical Hospital
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolnei M Caumo, M.D., PhD
Federal University of Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2015
First Posted
May 27, 2015
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
August 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05