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Neurofeedback for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02146495
Recruitment Status : Unknown
Verified May 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: EEG-NF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pain and Sleep Quality Measures Before and After a Course of EEG Neurofeedback in Fibromyalgia Patients
Study Start Date : May 2014
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Amygdala EEG-NF
Amygdala activity based EEG-NF
 Device: EEG-NF
Placebo Comparator: Sham EEG-NF
Sham EEG-NF
 Device: EEG-NF
No Intervention: Change in drug therapy
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
EEG-NF based on alpha/Theta ratio
 Device: EEG-NF


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: 2 months ]
    Pain measures during the treatment sessions period and one month after treatment cessation


Secondary Outcome Measures :
  1. Sleep Quality [ Time Frame: 2 months ]
    Sleep quality measures during the treatment sessions period and one month after treatment cessation


Other Outcome Measures:
  1. Brain pattern Changes [ Time Frame: 2 months ]
    some of the participants will undergo a functional MRI scan before and after the course of EEG-NF treatment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146495


Contacts
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Contact: Haggai Sjaron, MD haggaisharon@gmail.com

Locations
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Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, N/A = Not Applicable, Israel
Contact: Haggai Sharon, MD       haggais@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Haggai Sharon, MD Institute of Pain Mecine, Tel Aviv Sourasky Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02146495    
Other Study ID Numbers: TASMC-14-HS-0044-CTIL
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases