Neurostimulation Applied to Fibromyalgia

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

Official Title
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Neurostimulation Applied to Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Active tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ano-M1-cat-SO5 tDCS<br>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. | Device: Active tDCS<br>* Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.<br>* Other names: Transcranial direct current stimulation;|
| Experimental: ano-M1-cat-SO10 tDCS<br>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. | Device: Active tDCS<br>* Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.<br>* Other names: Transcranial direct current stimulation;|
| Sham Comparator: Sham tDCS<br>Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group. | Device: Sham tDCS<br>* Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.<br>* Other names: Transcranial direct current stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity level | Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life level | Changes in quality of life level assessed by Fibromyalgia Impact Questionnaire (FIQ). The FIQ is composed of 19 questions, which measure functional capacity, work status, psychological disturbances, physical and painful symptoms. The greater the impact of the disease, the greater the score found. The FIQ consists of 10 items. The first item contains 10 questions (a through j) related to physical functioning - each issue is evaluated on a four-point Likert scale. In items 2 and 3, the patient is asked to mark the number of days he felt well and the number of days that were unable to work (including housework) because of fibromyalgia-related symptoms. Items 4 to 10 are horizontal lines of 10 cm in length (Visual Analog Scale), in which the patient measures the difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Health assessment level | Changes in health assessed level assessed by Fibromyalgia Health Assessment (HAQ). It has eight categories: clothing and physical presence, wake up, feed, walk, hygiene, reach, footprint and other daily activities. For each of these categories, the patient indicates the degree of difficulty in four possible responses ranging from no difficulty = 0 to unable to do it = 3. The score for each category appears in the highest number of any of your items. The final HAQ score is the average of the scores of the eight categories and the higher the final score the worse the test result. Questionaire. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Sleep quality | Changes in sleep quality assessed by Pittsburgh Sleep Quality Index. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Cognitive function | Changes in the cognitive function assessed by Mini Mental State Examination. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Anxiety level | Changes in the anxiety level assessed by Beck Anxiety Inventory | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Depression level | Changes in the depression level assessed by Beck Depression Inventory | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Cortical electrical activity | Changes in the cortical electrical activity assessed by electroencephalogram | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 
| Resilience | Changes in the resilience assessed by Wagnild and Young Resilience Scale. It has 25 items described positively with likert type response ranging from 1 (totally disagree) to 7 (totally agree). Scale scores range from 25 to 175 points, with high values indicating high resilience. | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Neurostimulation, TDCS