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Neurofeedback for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EEG-NF
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Active Comparator

Arm Label

Amygdala EEG-NF

Sham EEG-NF

Change in drug therapy

A/T EEG-NF

Arm Description

Amygdala activity based EEG-NF

Sham EEG-NF

Pain and sleep quality measured after a change in drug therapy performed by the treating physician irrespective of the study - an observational arm

EEG-NF based on alpha/Theta ratio

Outcomes

Primary Outcome Measures

Pain
Pain measures during the treatment sessions period and one month after treatment cessation

Secondary Outcome Measures

Sleep Quality
Sleep quality measures during the treatment sessions period and one month after treatment cessation

Full Information

First Posted
May 21, 2014
Last Updated
May 21, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02146495
Brief Title
Neurofeedback for Fibromyalgia
Official Title
Pain and Sleep Quality Measures Before and After a Course of EEG Neurofeedback in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amygdala EEG-NF
Arm Type
Active Comparator
Arm Description
Amygdala activity based EEG-NF
Arm Title
Sham EEG-NF
Arm Type
Placebo Comparator
Arm Description
Sham EEG-NF
Arm Title
Change in drug therapy
Arm Type
No Intervention
Arm Description
Pain and sleep quality measured after a change in drug therapy performed by the treating physician irrespective of the study - an observational arm
Arm Title
A/T EEG-NF
Arm Type
Active Comparator
Arm Description
EEG-NF based on alpha/Theta ratio
Intervention Type
Device
Intervention Name(s)
EEG-NF
Primary Outcome Measure Information:
Title
Pain
Description
Pain measures during the treatment sessions period and one month after treatment cessation
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Sleep quality measures during the treatment sessions period and one month after treatment cessation
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Brain pattern Changes
Description
some of the participants will undergo a functional MRI scan before and after the course of EEG-NF treatment
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haggai Sjaron, MD
Email
haggaisharon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haggai Sharon, MD
Organizational Affiliation
Institute of Pain Mecine, Tel Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
State/Province
N/A = Not Applicable
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haggai Sharon, MD
Email
haggais@tlvmc.gov.il

12. IPD Sharing Statement

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Neurofeedback for Fibromyalgia

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