Occipital Transcranial Direct Current Stimulation in Fibromyalgia

July 27, 2009 updated by: University Hospital, Antwerp
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2620
        • Recruiting
        • University hospital Antwerp
        • Principal Investigator:
          • Mark Plazier, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline, directly after treatment, 3 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
base line, directly after treatment and 3 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Mark Plazier, M.D., University Hospital, Antwerp
  • Study Chair: Dirk De Ridder, M.D. PhD., University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2009

Last Update Submitted That Met QC Criteria

July 27, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDCS_BP_FMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Transcranial direct current stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe