An Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
Study Details
Study Description
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 |
---|---|---|
|
N/A |
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
Arms and Interventions
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
Primary Outcome Measures
- rTMS-induced change in fibromyalgia pain level [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
- treatment-induced changes of white-matter connectivity of the brain [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
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rambam Medical Center | Haifa | Israel |
Sponsors and Collaborators
- Rambam Health Care Campus
Investigators
- Principal Investigator: David Yarnitsky, MD, Prof, Rambam Health Care Campus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0106-15_CTIL