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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: 'sham' repeated transcranial magnetic stimulation; Device: active repeated transcranial magnetic stimulation

• Registration Number: NCT02572726
• Lead Sponsor: Rambam Health Care Campus

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 .

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Study Start: 2015-10-11
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
'sham' rTMS	'sham' repeated transcranial magnetic stimulation	'sham' repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
active rTMS	active repeated transcranial magnetic stimulation	active repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel