Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Antwerp University Hospital (UZA)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Fibromyalgia

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00947622

TDCS_BP_FMS

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Placebo stimulation

Placebo Comparator group

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)

Treatment:

Device: Transcranial direct current stimulation

Effective transcranial stimulation

Experimental group

Description:

Effective stimulation at the occipital head are for 1800 seconds at 2 mA, 3 times a week for 1 week

Treatment:

Device: Transcranial direct current stimulation