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A Prospective Trial to Explore the Efficacy of dTMS in Subjects With Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT02083588
First received: February 26, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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. 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.


Condition Intervention Phase
Fibromyalgia
Device: dTMS
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Trial to Explore the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • pain intensity - past 24h [ Time Frame: at baseline, and after treatment number 5, 10, 15 and 20, in addition to a final examination on follow up (two weeks after determination). ] [ Designated as safety issue: No ]
    Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ.


Secondary Outcome Measures:
  • pain dimensions [ Time Frame: baseline and follow up (two weeks after determination of treatment). ] [ Designated as safety issue: No ]
    1. Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire.
    2. Change of the impact of pain and FMS on quality of life, will be measured at the end point using the BPI items for pain interference.
    3. change of sensitivity to painful stimuli will be evaluated by physical measurements:

      • mechanical Temporal Summation - mTS
      • Sensory threshold
      • Thermal Pain Threshold
      • CPM
      • WPI
      • SSS


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open - single arm
All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
Device: dTMS
All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
Other Name: The Brainsway Ltd. H1-Coil

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • History of any metal in the head (outside the mouth).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  • History of head injury.
  • History of seizure or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of frequent or severe headaches.
  • Use of hearing aids for hearing loss.
  • Known history of cochlear implants.
  • History of drug abuse or alcoholism during the last year.
  • Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
  • Inadequate communication with the patient.
  • Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
  • Participation in current clinical study or clinical study within 30 days prior to this study.
  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: NCT02083588

Locations
Israel
Shalvata MHC Not yet recruiting
Hod Ha-sharon, Israel
Contact: maya hecht, research assistant    972-09-7478644    mayahe1@clalit.org.il   
Contact: uri nitzan, MD    972-7478644    urini@clalit.org.il   
Principal Investigator: Uri Nitzan, MD         
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT02083588     History of Changes
Other Study ID Numbers: FMS_01
Study First Received: February 26, 2014
Last Updated: March 10, 2014
Health Authority: Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Shalvata Mental Health Center:
Fibromyalgia
dTMS
pain
PFC
Subjects with Fibromyalgia

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

ClinicalTrials.gov processed this record on November 25, 2014