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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
  Purpose

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 Intervention Phase
Fibromyalgia
 Device: Transcranial direct current stimulation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: July 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Dr. Dirk De Ridder, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00947622     History of Changes
Other Study ID Numbers: TDCS_BP_FMS
Study First Received: July 27, 2009
Last Updated: July 27, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on May 23, 2013