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Trial record 7 of 107 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Neurostimulation Applied to Fibromyalgia (NeuroFibro)

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ClinicalTrials.gov Identifier: NCT03384888
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Géssika Araújo de Melo, Federal University of Paraíba

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

Condition or disease Intervention/treatment
Fibromyalgia Device: Active tDCS Device: Sham tDCS

Study Type : Interventional
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Neurostimulation Applied to Fibromyalgia
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ano-M1-cat-SO5 tDCS
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
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.
Other Name: Transcranial direct current stimulation
Experimental: ano-M1-cat-SO10 tDCS
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
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.
Other Name: Transcranial direct current stimulation
Sham Comparator: Sham tDCS
Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.
Device: Sham tDCS
Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
Other Name: Transcranial direct current stimulation



Primary Outcome Measures :
  1. Pain [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in pain level, assessed by Visual Analogue Scale.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in quality of life level assessed by Fibromyalgia Impact Questionnaire (FIQ).

  2. Health assessment [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in health assessed level assessed by Fibromyalgia Health Assessment Questionaire.

  3. Sleep quality [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.

  4. Cognitive function [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the cognitive function assessed by Mini Mental State Examination.

  5. Anxiety [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the anxiety level assessed by Beck Anxiety Inventory

  6. Depression [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the depression level assessed by Beck Depression Inventory

  7. Cortical electrical activity [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the cortical electrical activity assessed by electroencephalogram

  8. Resilience [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the resilience assessed by Wagnild and Young Resilience Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384888


Contacts
Contact: Eliane Oliveira, Dr 55 (83) 3216-7200 elianeao@uol.com.br
Contact: Géssika Melo 55 (83) 3216-7200 gessika.fisio@gmail.com

Locations
Brazil
Universidade Federal da Paraiba Recruiting
João Pessoa, Paraíba, Brazil, 58.051-900
Contact: Eliane Oliveira, Dr    55 (83) 3216-7200      
Sponsors and Collaborators
Federal University of Paraíba

Responsible Party: Géssika Araújo de Melo, Eliane Araújo de Oliveira, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT03384888     History of Changes
Other Study ID Numbers: Eliane Araújo de Oliveira
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Géssika Araújo de Melo, Federal University of Paraíba:
Fibromyalgia, Neurostimulation, TDCS

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