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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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Transcranial direct current stimulation Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Study Start Date : July 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)
Device: Transcranial direct current stimulation
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
Device: Transcranial direct current stimulation
Transcranial Direct current stimulation


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947622


Contacts
Contact: Mark Plazier, M.D. +32 3 821 3788 mark.plazier@uza.be

Locations
Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2620
Principal Investigator: Mark Plazier, M.D.         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Study Chair: Dirk De Ridder, M.D. PhD. University Hospital, Antwerp
Principal Investigator: Mark Plazier, M.D. University Hospital, Antwerp
More Information

Responsible Party: Prof. Dr. Dirk De Ridder, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00947622     History of Changes
Other Study ID Numbers: TDCS_BP_FMS
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009

Keywords provided by University Hospital, Antwerp:
Fibromyalgia
Neuromodulation
Transcranial Direct Current Stimulation
Occipital

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases