Clinical trial NCT02572726: An Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
Official title: Integration of Neuroimaging and Transcranial Magnetic Stimulation: an Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 .

Eligibility 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.

Primary outcomes:
measure: rTMS-induced change in fibromyalgia pain level
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: treatment-induced changes of white-matter connectivity of the brain
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: David Yarnitsky, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: