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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT02572726
Collaborator
(none)
100
1
2
61.7
1.6

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
  • Device: active repeated transcranial magnetic stimulation
  • Device: 'sham' repeated transcranial magnetic stimulation
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

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Integration of Neuroimaging and Transcranial Magnetic Stimulation: an Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
Actual Study Start Date :
Oct 11, 2015
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Dec 1, 2020

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

  1. 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

  1. 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

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT02572726
Other Study ID Numbers:
  • 0106-15_CTIL
First Posted:
Oct 9, 2015
Last Update Posted:
May 20, 2021
Last Verified:
May 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2021