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Occipital Transcranial Direct Current Stimulation in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00947622
Recruitment Status : Unknown
Verified July 2009 by University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 28, 2009
Last Update Posted Date July 28, 2009
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Official Title  ICMJE Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Device: Transcranial direct current stimulation
Transcranial Direct current stimulation
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947622
Other Study ID Numbers  ICMJE TDCS_BP_FMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Dirk De Ridder, University Hospital Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dirk De Ridder, M.D. PhD. University Hospital, Antwerp
Principal Investigator: Mark Plazier, M.D. University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date July 2009

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