Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.

Official Title
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Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

Conditions
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Fibromyalgia, Chronic Pain

Intervention / Treatment
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* Device: High Definition transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providing informed consent to participate in the study 18 to 85 years old, both male and female Have a diagnosis of Fibromyalgia Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine. Exclusion Criteria: Pregnancy Contraindications to tDCS: metal in the head or implanted brain medical devices History of alcohol or drug abuse within the past 6 months as self-reported Use of carbamazepine within the past 6 months as self-reported Severe depression (with a score of >30 in the Beck Depression Inventory) Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines History of unexplained fainting spells as self-reported Neurosurgery as self-reported

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active anodal HD-tDCS<br>Subjects will undergo 20 minutes active HD-tDCS. | Device: High Definition transcranial Direct Current Stimulation<br> <br> * Other names: 4X1 low-intensity direct current stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS) | Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain. | approximately 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who achieve clinical response | We will count the number of subjects who achieve clinical response (as defined in Aim 1 as a 50% reduction in baseline VAS) for the duration of the trial. | Approximately 4.5 months | 
| Measurement of sensory and auditory evoked potentials | We will measure brain pain response using electroencephalography (EEG) to measure somatosensory Event Related Potentials (ERPs) with a heat pain threshold device. We will also measure auditory ERPs. We will investigate the relationship between these ERP measurements and overall clinical response of patients (as outlined in Aim 1 and Aim 2) | Approximately 4.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial stimulation, direct current