Overview

This trial is active, not recruiting.

Condition fibromyalgia
Treatments tdcs neuroconn dc-stimulator plus, sham tdcs
Sponsor University Hospital of North Norway
Collaborator Stiftelsen Helse og Rehabilitering
Start date December 2011
End date June 2013
Trial size 70 participants
Trial identifier NCT01598181, 2010/2256/REK n, UNorthNorway

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
tdcs neuroconn dc-stimulator plus model 0021
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
(Sham Comparator)
tDCS fades out after 20 sec. administered double blind by coded program.
tdcs neuroconn dc-stimulator plus model 0021
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
sham tdcs
similar montage and time as active. Stimulation fades out after 20 sec.

Primary Outcomes

Measure
Perceived pain
time frame: Change in VAS from baseline up to 49 days.

Secondary Outcomes

Measure
Cerebral pain processing
time frame: Change from baseline to post treatment. 7 days.
Rating scales (HADS, SCL90, SF36, FIQ)
time frame: Change from baseline to post treatment. 30 days post treatment. Up to 65 days.
Perceived pain, natural history
time frame: Baseline compared to post-treatment. Up to 65 days
Perceived stress and activation
time frame: Change in VAS from baseline to during treatment and after treatment. Up to 49 days.
Perceived stress and activation, natural history
time frame: Baseline compared to post-treatment. Up to 65 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.