Neurofeedback for Fibromyalgia

Study Overview
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Brief Summary
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Fibromyalgia is a clinical syndrome characterized by extensive chronic pain. Today, the main theory argues the origin of the pain is central sensitization which is en amplification of processing and transferring neuronal signals. Patients usually suffers a wide range of symptoms: extensive pain, chronic fatigue disorders of sleep (having trouble falling asleep, fragmented sleep and early awakening) , mood disorders and cognitive damage. To treat the sleep disorder, the pain and the depuration with Fibromyalgia patients is a complex clinical challenge that usually requires combination of different medicines (short term analgesic + long term analgesics + anti-depressives and so on). Patients are also referred to other treatments such as cognitive behavioral therapy (CBT), occupational therapy treatment, phycisal therapy, alternative medicine and so on. Another such non-medical treatment is to try and modifies the patterns of activity of the patient's brain. One approach that draws attention in the last few years is EEG based neuro-feedback (NF). EEG NF is a closed circuit brain computer Interface (BCI) in which the patient gets a feedback from his or her own brain that signifies a certain mental state. The brain-patient feedback allows to train patients in performing a voluntary change of a dedicated brain area, such as pain related areas. In this study we intend to assess the effect of two different EEG-NF protocols targeting different brain areas as compared to placebo (sham) NF and drug therapy on pain and sleep quality measures in fibromyalgia patients.

Official Title
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Pain and Sleep Quality Measures Before and After a Course of EEG Neurofeedback in Fibromyalgia Patients

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: EEG-NF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-85 Fibromyalgia diagnosis by a specialist in internal medicine, Neurology or Pain medicine Subjective complaints about sleep disorder Pain does not stop despite regular medication- at least three events per week of pain ranked five out of ten chronic drug treatment should not be change in the near future for the three EEG groups. A change in drug therapy ordered by the treating physician for the drug-change observational group Within the part of the experiment that requires MRI scan, accepted criteria for MRI scan for medical use will be followed, according to the procedures prescribed in the MRI institute of the Tel-Aviv Sourasky medical center. Exclusion Criteria: Non-Hebrew speakers Diagnosis of another pain chronic syndrome (such as migraine) History of psychiatric or neurological diseases requiring hospitalization

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amygdala EEG-NF<br>Amygdala activity based EEG-NF | Device: EEG-NF<br> <br> |
| Placebo Comparator: Sham EEG-NF<br>Sham EEG-NF | Device: EEG-NF<br> <br> |
| No Intervention: Change in drug therapy<br>Pain and sleep quality measured after a change in drug therapy performed by the treating physician irrespective of the study - an observational arm | |
| Active Comparator: A/T EEG-NF<br>EEG-NF based on alpha/Theta ratio | Device: EEG-NF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain measures during the treatment sessions period and one month after treatment cessation | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Sleep quality measures during the treatment sessions period and one month after treatment cessation | 2 months |