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Occipital Transcranial Direct Current Stimulation in Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospital, Antwerp.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00947622
First received: July 27, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 27, 2009
July 27, 2009
July 2009
October 2009   (final data collection date for primary outcome measure)
Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire [ Time Frame: baseline, directly after treatment, 3 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale [ Time Frame: base line, directly after treatment and 3 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Occipital Transcranial Direct Current Stimulation in Fibromyalgia

The aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and the design is a cross-over design.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Fibromyalgia
Device: Transcranial direct current stimulation
Transcranial Direct current stimulation
  • Placebo Comparator: Placebo stimulation
    Placebo stimulation at the occipital head area for 1800 seconds at 0 mA, three times a week, during one week (with seconds of stimulation to get onset tingling sensation)
    Intervention: Device: Transcranial direct current stimulation
  • Experimental: Effective transcranial stimulation
    Effective stimulation at the occipital head are for 1800 seconds at 2 mA, 3 times a week for 1 week
    Intervention: Device: Transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
November 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients suffering from Fibromyalgia, diagnosed according to the criteria of the ACR-90, with exclusion of other pathologies mimicking the FMS related symptoms by a M.D. of the department of Physical Medicine and Rehabilitation (UZA, Belgium)
  • Dutch speaking
  • Stability of medication during the study

Exclusion Criteria:

  • History of substance abuse, unless treated and in remission during 6 months
  • Cardiac disease, implanted pace-maker or defibrillator
  • History of epileptic insults
  • Severe organic comorbidity
  • Psychiatric comorbidity with psychotic symptoms
  • Pregnancy
Female
18 Years to 65 Years
No
Contact: Mark Plazier, M.D. +32 3 821 3788 mark.plazier@uza.be
Belgium
 
NCT00947622
TDCS_BP_FMS
No
Prof. Dr. Dirk De Ridder, University Hospital Antwerp
University Hospital, Antwerp
Not Provided
Study Chair: Dirk De Ridder, M.D. PhD. University Hospital, Antwerp
Principal Investigator: Mark Plazier, M.D. University Hospital, Antwerp
University Hospital, Antwerp
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP