Neurostimulation Applied to Fibromyalgia

NCT03384888 | Unknown

• 1 other identifier: Eliane Araújo de Oliveira
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Neurostimulation, TDCS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of life level

  Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

• Health assessment level

  Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

• Sleep quality

  Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

• Cognitive function

  Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

• Anxiety level

  Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

Study Arms (3)

ano-M1-cat-SO5 tDCS

EXPERIMENTAL

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

ano-M1-cat-SO10 tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

Active tDCS DEVICE

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.

Also known as: Transcranial direct current stimulation

ano-M1-cat-SO10 tDCS; ano-M1-cat-SO5 tDCS

Sham tDCS DEVICE

Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.

Also known as: Transcranial direct current stimulation

Sham tDCS

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Universidade Federal da Paraiba

João Pessoa, Paraíba, 58.051-900, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eliane Araújo de Oliveira

Model Details: 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).

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: May 15, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

BR (1)