Back to resultsOccipital Transcranial Direct Current Stimulation in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Neuromodulation, Transcranial Direct Current Stimulation, Occipital
Eligibility 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
Sites / Locations
- University Hospital AntwerpRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo stimulation
Effective transcranial stimulation
Arm Description
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)
Effective stimulation at the occipital head are for 1800 seconds at 2 mA, 3 times a week for 1 week
Outcomes
Primary Outcome Measures
Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire
Secondary Outcome Measures
Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale
Full Information
NCT ID
NCT00947622
First Posted
July 27, 2009
Last Updated
July 27, 2009
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00947622
Brief Title
Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Official Title
Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Neuromodulation, Transcranial Direct Current Stimulation, Occipital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo stimulation
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Effective transcranial stimulation
Arm Type
Experimental
Arm Description
Effective stimulation at the occipital head are for 1800 seconds at 2 mA, 3 times a week for 1 week
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Transcranial Direct current stimulation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Plazier, M.D.
Phone
+32 3 821 3788
Email
mark.plazier@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ridder, M.D. PhD.
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Plazier, M.D.
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2620
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Plazier, M.D.
12. IPD Sharing Statement
Learn more about this trial
Occipital Transcranial Direct Current Stimulation in Fibromyalgia
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