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

NCT02572726 | Completed

• 1 other identifier: 0106-15_CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• rTMS-induced change in fibromyalgia pain level

  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

  through study completion, an average of 2 year

Secondary Outcomes (1)

• treatment-induced changes of white-matter connectivity of the brain

  through study completion, an average of 2 year

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

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

Device: active repeated transcranial magnetic stimulation

'sham' rTMS

SHAM COMPARATOR

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

Device: 'sham' repeated transcranial magnetic stimulation

Interventions

active repeated transcranial magnetic stimulation DEVICE

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

active rTMS

'sham' repeated transcranial magnetic stimulation DEVICE

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

'sham' rTMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• David Yarnitsky, MD, Prof

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 9, 2015
• Study Start: October 11, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

IL (1)