Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Gave informed consent for participation in the study.
Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 months before enrollment and remains stable throughout the study.
Gave informed consent for participation in the study.
Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 months before enrollment and remains stable throughout the study.

Exclusion Criterias

Use of hearing aids for hearing loss.
History of frequent or severe headaches.
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
...
Use of hearing aids for hearing loss.
History of frequent or severe headaches.
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
Inadequate communication with the patient.
History of epilepsy or seizure in first degree relatives.
Known history of cochlear implants.
Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
History of seizure or heat convulsion.
History of drug abuse or alcoholism during the last year.
Participation in current clinical study or clinical study within 30 days prior to this study.
Subjects diagnosed with a current primary psychiatric condition - including major depression or major personality disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria - or a history of substance abuse will be excluded, as well as pregnant subjects.
Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
History of any metal in the head (outside the mouth).
Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
History of head injury.

Summary

Conditions
Fibromyalgia
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in the prime of life, causing severe reduction in quality of life and productivity, as well as social isolation, anxiety, and depression. FMS has recently been estimated to affect approximately 2.6% of the Israel...

Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in the prime of life, causing severe reduction in quality of life and productivity, as well as social isolation, anxiety, and depression. FMS has recently been estimated to affect approximately 2.6% of the Israeli population. Over the last decade, it has repeatedly been shown that Transcranial Magnetic Stimulation (TMS) of the primary motor cortex (M1) induces an analgesic effect both in experimental pain, as well as in various chronic pain conditions, possibly by activating intrinsic pain-modulation systems. Thus, the purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS. The study will take place in Shalvata Mental Health Center, After receiving the hospital's BRI approval. Forty FMS patients between 18-65 years of age will sign an informed consent form, and be randomized to an active arm (dTMS) and a placebo arm (sham-dTMS). Twenty treatments will be delivered to each subject over a period of 4 weeks. At base-line subjects will complete a series of epidemiological and clinical questionnaires (assessing symptoms of FMS, depression, pain, anxiety), as well as pain sensation and modulation tests. At the termination of the study and two weeks after the final treatment all questionnaires and physical measurements will be re-administered for a final assessment of post-treatment status comparison with initial status The importance of the study lies in its potential to: 1) provide evidence for the efficacy of dTMS in treating patients suffering from FMS 2)enhance the investigators understanding of the pathophysiology of FMS and its underlying pain perception and modulation mechanisms 3) explore the role of the Dorso-Lateral-Prefrontal-Cortex (DLPC) in modulating pain and as a possible target to further therapeutic interventions in FMS.

Inclusion Criterias

Gave informed consent for participation in the study.
Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 months before enrollment and remains stable throughout the study.
Gave informed consent for participation in the study.
Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 months before enrollment and remains stable throughout the study.

Exclusion Criterias

Use of hearing aids for hearing loss.
History of frequent or severe headaches.
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
...
Use of hearing aids for hearing loss.
History of frequent or severe headaches.
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
Inadequate communication with the patient.
History of epilepsy or seizure in first degree relatives.
Known history of cochlear implants.
Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
History of seizure or heat convulsion.
History of drug abuse or alcoholism during the last year.
Participation in current clinical study or clinical study within 30 days prior to this study.
Subjects diagnosed with a current primary psychiatric condition - including major depression or major personality disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria - or a history of substance abuse will be excluded, as well as pregnant subjects.
Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
History of any metal in the head (outside the mouth).
Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
History of head injury.

Locations

Hod Ha-sharon
Hod Ha-sharon

Tracking Information

NCT #
NCT02083588
Collaborators
Not Provided
Investigators
Not Provided