Neurostimulation Applied to Fibromyalgia

NCT ID: NCT03384888

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Active tDCS

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Active tDCS

Intervention Type 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.

Sham tDCS

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sham tDCS

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transcranial direct current stimulation Transcranial direct current stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Géssika Araújo de Melo

Eliane Araújo de Oliveira

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal da Paraiba

João Pessoa, Paraíba, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eliane Araújo de Oliveira

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurotropin Treatment of Fibromyalgia
NCT00366535 COMPLETED PHASE2
Pain Management Techniques for Fibromyalgia
NCT00086060 COMPLETED PHASE1/PHASE2
A Study of Duloxetine in Fibromyalgia
NCT01552057 COMPLETED PHASE3