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

Fibromyalgia Clinical Trial

Official title:

Integration of Neuroimaging and Transcranial Magnetic Stimulation: an Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572726
• Other study ID #: 0106-15_CTIL
• Status: Completed
• Phase: N/A
• Start date: October 11, 2015
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2021
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia

Intervention

Device:
• active repeated transcranial magnetic stimulation
ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex
• 'sham' repeated transcranial magnetic stimulation
ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	through study completion, an average of 2 year