Neurostimulation Applied to Fibromyalgia (NeuroFibro)

Federal University of Paraíba

Status: Unknown

Conditions: Fibromyalgia

Treatments: Device: Sham tDCS; Device: Active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03384888

Eliane Araújo de Oliveira

Details and patient eligibility

About

NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.

Enrollment: 59 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
• (2) been diagnosed for at least three months;
• (3) be female;
• (4) be in the age group between 25 and 60 years of age; and
• (5) sign the consent form.

Exclusion criteria

• (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
• (2) illiterate;
• (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
• (4) history of convulsion;
• (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
• (6) be pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 3 patient groups

ano-M1-cat-SO5 tDCS

Experimental group

Description:

Participants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days.

Treatment:

Device: Active tDCS

ano-M1-cat-SO10 tDCS

Experimental group

Description:

Participants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days.

Treatment:

Device: Active tDCS

Sham tDCS

Sham Comparator group

Description:

Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.

Treatment:

Device: Sham tDCS