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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
active repeated transcranial magnetic stimulation
'sham' repeated transcranial magnetic stimulation
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rambam Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active rTMS

'sham' rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

treatment-induced changes of white-matter connectivity of the brain
White-matter connectivity will be measured using the method of diffusion tensor imaging of the brain

Full Information

First Posted
October 6, 2015
Last Updated
May 19, 2021
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02572726
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 11, 2015 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Active Comparator
Arm Description
active repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
Arm Title
'sham' rTMS
Arm Type
Sham Comparator
Arm Description
'sham' repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
Intervention Type
Device
Intervention Name(s)
active repeated transcranial magnetic stimulation
Intervention Description
ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex
Intervention Type
Device
Intervention Name(s)
'sham' repeated transcranial magnetic stimulation
Intervention Description
ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex
Primary Outcome Measure Information:
Title
rTMS-induced change in fibromyalgia pain level
Description
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
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
treatment-induced changes of white-matter connectivity of the brain
Description
White-matter connectivity will be measured using the method of diffusion tensor imaging of the brain
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yarnitsky, MD, Prof
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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