Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00947622
• Other study ID #: TDCS_BP_FMS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 27, 2009
• Last updated: July 27, 2009
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: University Hospital, Antwerp
• Contact: Mark Plazier, M.D.
• Phone: +32 3 821 3788
• Email: mark.plazier[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Transcranial direct current stimulation
Transcranial Direct current stimulation

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire		baseline, directly after treatment, 3 weeks after treatment	No
Secondary	Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale		base line, directly after treatment and 3 weeks after treatment	No