Identifying Neuroimaging Biomarkers, Demographic, Personality and Sensory Factors for Predicting Extreme Pain Responses to Various Experimental Pain Stimulations in Healthy Subjects

NCT03436264 | Unknown DMC

• 1 other identifier: 0448-17
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The proneness to react to noxious stimuli varies widely between individuals and pain ratings of seemingly identical noxious stimuli may range from "no pain" to "excruciating pain" . Imaging studies in healthy subjects have provided useful information on the identification of the inter-individual variability in pain perception \[2,3,4\]. These studies have shown that subjective pain reports are closely related to the degree of neuronal activity in several brain regions known to be identified in pain processing. Furthermore, there has been a growing interest in understanding structural and functional mechanisms of inter-individual variability in responses to identical noxious stimuli \[5,6,7\]. Yet, the relationship between pain perception and various anatomical and functional connectivity within resting state brain networks is not completely understood. With regard to the anatomical correlate of pain sensitivity, differences in grey matter may reflect neural processes contributing to the construction and modulation of pain in healthy individuals. As such, studies are inconsistent regarding this issue, showing positive \[7\] or inverse connections \[6\] between pain sensitivity and brain morphology. The inconsistency regarding this issue warrant further investigation which may elucidate the relationship between differences in pain sensitivity and regional grey matter and may provide novel insights into brain mechanisms contributing to that topic. Understanding brain morphology and connectivity within specific regions associated with pain processing can provide reliable anchor for the individual differences in pain response. A widely used approach to examine brain morphology from MRI images is voxel based morphometry (VBM). VBM tests for statistically significant differences in regional gray matter (GM) density between study groups, and its temporal changes. Diffusion tensor imaging (DTI) is a type of diffusion weighted imaging with the advantage of being able to resolve individual functional tracts within the white matter (WM) thus, DTI parameters serve as indirect measures of structural connectivity via the degree of integrity of WM tracts.

Conditions

Pain; Individual Difference

Outcome Measures

Primary Outcomes (1)

• fMRI diffrences

  a. Both subgroups will demonstrate differences in gray matter density and cortical thickness in key cortical regions that are responsible for the processing and modulation of sensory stimuli, such as primary somatosensory cortex (S1), cingulate cortex (ACC/MCC/PCC), prefrontal cortex (PFC including OFC) and insula.

  2 years

Study Arms (2)

high sensitivity to pain

Other: MRI

low sensitivity to pain

Other: MRI

Interventions

MRI OTHER

fMRI

high sensitivity to pain; low sensitivity to pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 196 healthy participants. Of these, 48 patients will undergo brain imaging

You may qualify if:

• Healthy males and females, over the age of 18, free from chronic pain of any type.
• No medication use (except for oral contraceptives).
• Able to understand the purpose and instructions of the study and to sign an informed consent.

You may not qualify if:

• Pregnant women
• Inability to comply with study protocol.
• A diagnosis of Raynaud's Syndrome
• Subjects with metal implants of any kind (including pace maker) and Claustrophobia will be excluded from the study.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eisenberg

CONTACT

972502061091; e_eisenberg@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elon Eisenberg MD Professor of Neurology and Pain Medicine Head, Pain Research Unit Institute of Pain Medicine Rambam Health Care Campus

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

IL (1)