Trial record 53 of 133 for:    fibromyalgia | Open Studies | Interventional Studies

Neurofeedback for Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT02146495
First received: May 21, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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 Intervention
Fibromyalgia
Device: EEG-NF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Pain and Sleep Quality Measures Before and After a Course of EEG Neurofeedback in Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Pain [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Pain measures during the treatment sessions period and one month after treatment cessation


Secondary Outcome Measures:
  • Sleep Quality [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Sleep quality measures during the treatment sessions period and one month after treatment cessation


Other Outcome Measures:
  • Brain pattern Changes [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    some of the participants will undergo a functional MRI scan before and after the course of EEG-NF treatment


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02146495

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

Locations
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
Principal Investigator: Haggai Sharon, MD Institute of Pain Mecine, Tel Aviv Sourasky Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02146495     History of Changes
Other Study ID Numbers: TASMC-14-HS-0044-CTIL 
Study First Received: May 21, 2014
Last Updated: May 21, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2016