NCT02358902

Brief Summary

This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
Last Updated

February 9, 2015

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

December 19, 2014

Last Update Submit

February 3, 2015

Conditions

Fibromyalgia

Keywords

Transcranial Direct Current StimulationExerciseFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Numeric Scale (VNS)

    Pain intensity is measured using a scale from 0 to 10. A straight 10 cm line is displayed for the subject enumerated from zero to 10, where zero represents no pain and 10 the worst pain possible. Subjects should mark the number that most represents the symptom of pain at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.

    Up to 2 months

Secondary Outcomes (1)

  • Change in Visual Numeric Scale for Anxiety

    Up to 2 months

Other Outcomes (3)

  • Change in Pressure Pain Threshold (PPT)

    Up to 2 months

  • Change in Diffuse Noxious Inhibitory Control (DNIC-like effects)

    Up to 2 months

  • Change in SF-36 questionnaire of quality of life

    Up to 2 months

Study Arms (3)

Group A

EXPERIMENTAL

tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention

Device: tDCSProcedure: active intervention of aerobic exercise

Group B

EXPERIMENTAL

AE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany)

Procedure: active intervention of aerobic exerciseDevice: placebo tDCS

Group C

EXPERIMENTAL

tDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany)

Device: tDCSProcedure: placebo AE

Interventions

tDCSDEVICE

tDCS - DC stimulator, Neurocom, Germany

Group AGroup C
active intervention of aerobic exercisePROCEDURE

different types of aerobic exercise

Group AGroup B
placebo tDCSDEVICE

only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)

Group B
placebo AEPROCEDURE

the procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill

Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Fibromyalgia according to the American College of Rheumatology
  • Have completed high school
  • Age between 18 and 65 years old

You may not qualify if:

  • Were on medication for pain control for less than two months
  • In treatment of depression for less than two months
  • Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope
  • Pregnant women and infants
  • Possessing metallic implant in the brain
  • In use of illicit drugs
  • That were in some kind of physical treatment for less than two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

    PMID: 17133529RESULT

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Marcel Simis, MD PhD

    Institute of Physical Medicine and Rehabilitation, Clinicas Hospital, Faculty of Medicine, University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

February 9, 2015

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 9, 2015

Record last verified: 2014-12