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

NCT ID: NCT02572726

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-11
• Study Completion Date: 2020-12-01

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 .

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

active rTMS

active repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions

Group Type: ACTIVE_COMPARATOR

active repeated transcranial magnetic stimulation

Intervention Type: DEVICE

ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex

'sham' rTMS

'sham' repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions

Group Type: SHAM_COMPARATOR

'sham' repeated transcranial magnetic stimulation

Intervention Type: DEVICE

ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex

Interventions

active repeated transcranial magnetic stimulation

ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex

Intervention Type: DEVICE

'sham' repeated transcranial magnetic stimulation

ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Yarnitsky, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

0106-15_CTIL

Identifier Type: -

Identifier Source: org_study_id