Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

University Hospital of North Norway

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: sham tDCS; Device: tDCS NeuroConn DC-stimulator plus

Study type: Interventional

Funder types: Other

Identifiers

NCT01598181

2010/2256/REK n

UNorthNorway

Details and patient eligibility

About

The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

Full description

Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.

Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:

1. To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
2. To investigate tDCS induced functional changes in the brain by using fMRI.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
• Mean VAS > 4 daily 2 weeks prior to study).

Exclusion criteria

• Severe mental disease
• CNS disease
• Mental retardation
• Age < 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

active tDCS

Experimental group

Treatment:

Device: tDCS NeuroConn DC-stimulator plus

sham tDCS

Sham Comparator group

Description:

tDCS fades out after 20 sec. administered double blind by coded program.

Treatment:

Device: tDCS NeuroConn DC-stimulator plus

Device: sham tDCS