NCT00947622

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 28, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

July 27, 2009

Last Update Submit

July 27, 2009

Conditions

Fibromyalgia

Keywords

FibromyalgiaNeuromodulationTranscranial Direct Current StimulationOccipital

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Placebo stimulation

PLACEBO COMPARATOR

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

Effective transcranial stimulation

EXPERIMENTAL

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

Interventions

Transcranial direct current stimulationDEVICE

Transcranial Direct current stimulation

Effective transcranial stimulationPlacebo stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dutch speaking
  • Stability of medication during the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2620, Belgium

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Dirk De Ridder, M.D. PhD.

    University Hospital, Antwerp

    STUDY CHAIR

  • Mark Plazier, M.D.

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Plazier, M.D.

CONTACT

+32 3 821 3788mark.plazier@uza.be

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

July 28, 2009

Record last verified: 2009-07

Locations

BE(1)