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An Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain

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ClinicalTrials.gov Identifier: NCT02572726
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Study Description
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Brief Summary:
Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is unknown. The proposed research will use TMS in conjunction with brain imaging and electrophysiology to examine cortical plasticity and connectivity modifications induced by repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia) states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem mechanisms involved in EA and to investigate connectivity changes between cortical and sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related personality variables will be used to assess individual differences in neuroplasticity within the EA systems in both healthy subjects and chronic pain patients.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: active repeated transcranial magnetic stimulation Device: 'sham' repeated transcranial magnetic stimulation Not Applicable

Detailed Description:
Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is unknown. The proposed research will use TMS in conjunction with brain imaging and electrophysiology to examine cortical plasticity and connectivity modifications induced by repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia) states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem mechanisms involved in EA and to investigate connectivity changes between cortical and sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related personality variables will be used to assess individual differences in neuroplasticity within the EA systems in both healthy subjects and chronic pain patients .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Integration of Neuroimaging and Transcranial Magnetic Stimulation: an Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
Actual Study Start Date : October 11, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: active rTMS
active repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
 Device: active repeated transcranial magnetic stimulation
ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex
Sham Comparator: 'sham' rTMS
'sham' repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
 Device: 'sham' repeated transcranial magnetic stimulation
ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex


Outcome Measures
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Primary Outcome Measures :
  1. rTMS-induced change in fibromyalgia pain level [ Time Frame: through study completion, an average of 2 year ]
    Fibromyalgia pain level will be measured using the numerical pain scale; the patients will be asked to rate their mean pain level over the last 5 days


Secondary Outcome Measures :
  1. treatment-induced changes of white-matter connectivity of the brain [ Time Frame: through study completion, an average of 2 year ]
    White-matter connectivity will be measured using the method of diffusion tensor imaging of the brain


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a prior FMS diagnosis by a rheumatologist or pain specialist based on American College of Rheumatology (ACR) preliminary diagnostic criteria for fibromyalgia
  • healthy subjects - no pain/psychiatry/neurological diseases

Exclusion Criteria:

  • other chronic pain, psychiatric or neurological diseases. All will be asked to withdraw from any pain-relieving medications for 24h before the testing.
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): NCT02572726


Contacts
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Contact: David Yarnitsky, MD, Prof +972 502062700
Contact: Yelena Granovsky, PhD +972 502065750

Locations
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Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: David Yarnitsky, Prof.    +972-4-8542605      
Principal Investigator: David Yarnitsky, Prof.         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: David Yarnitsky, MD, Prof Rambam Health Care Campus
More Information
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02572726    
Other Study ID Numbers: 0106-15_CTIL
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Fibromyalgia
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases