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

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

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

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: tDCS NeuroConn DC-stimulator plus
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br> | Device: tDCS NeuroConn DC-stimulator plus<br>* Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.<br>* Other names: serial-no 0337;|
| Sham Comparator: sham tDCS<br>tDCS fades out after 20 sec. administered double blind by coded program. | Device: tDCS NeuroConn DC-stimulator plus<br>* Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.<br>* Other names: serial-no 0337;Device: sham tDCS<br>* similar montage and time as active. Stimulation fades out after 20 sec.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain | Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on pain. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome). | Change in VAS from baseline up to 49 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral pain processing | Phillps tesla 1.5 fMRi, pathway pain stimulator (Medoc, Israel) fMRI under pain stimulation for 60 participants. 20 recieve active tDCS, 20 recieve sham-tDCS, 20 age and gender matched (matched to active tDCS group) healthy controls. Baseline scan, post treatment scan. | Change from baseline to post treatment. 7 days. | 
| Rating scales (HADS, SCL90, SF36, FIQ) | Time from inclusion to treatment start determines 30\14 days. Rating scales on Samsung Galaxy tab 10.1. HADS mesure anxiety and depression, SCL 90 measure symtoms of mental illness, SF36 mesure health related life quality, FIQ mesure symptom severity in fibromyalgia. | Change from baseline to post treatment. 30 days post treatment. Up to 65 days. | 
| Perceived pain, natural history | Pain (intensity and unpleasentness) measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period. | Baseline compared to post-treatment. Up to 65 days | 
| Perceived stress and activation | Stress and activation measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on stress and activation. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) Measured using the same instrumet as the primary outcome. | Change in VAS from baseline to during treatment and after treatment. Up to 49 days. | 
| Perceived stress and activation, natural history | Stress and activation measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period. | Baseline compared to post-treatment. Up to 65 days |