Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS

NCT01904097 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-07-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct current stimulation.

Conditions

Interventions

DRUG

Pregabalin

Pregabalin 150 mg per oral BID (i.e. twice per day).

OTHER

Transcranial Direct Current Stimulation

The tDCS consists of application of low intensity direct current (2 mA), with the anode placed in the dominant motor cortex (M1) and the cathode in the ipsilateral supraorbital region during 30 minutes each session, using sponge electrodes soaked with normal saline solution.

OTHER

Sham Transcranial Direct Current Stimulation

The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 30 minutes that the session lasts.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Wolnei Caumo, MD, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904097 on ClinicalTrials.gov