Quantitative SSEP and EEG as Objective Pain Biomarker

• ClinicalTrials.gov Identifier: NCT03495180
• Recruitment Status: Active, not recruiting
• First Posted: April 11, 2018
• Last Update Posted: March 7, 2022
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Michael Froelich, University of Alabama at Birmingham

Study Description

Brief Summary:

Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain. And machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.

This is a pilot study to investigate whether components of a person's electrical brain activity do reflect pain sensation.

Condition or disease	Intervention/treatment	Phase
Pain	Other: Standard EEG or SSEP	Not Applicable

Detailed Description:

Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and/or chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain and machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.

The establishment of a biomarker of pain is a key requirement for understanding the person-specific effects of anesthetic and analgesic drugs. An objective pain measure will be an integral part in the planning of an anesthetic and potentially enable the researchers to answer the question whether proper matching of the anesthetic or analgesic dose to a person's individual profile will result in better cognitive recovery from anesthesia.

There are several approaches to quantifying pain in an objective fashion. These approaches are based on the observation of afferent signals to the brain, brain integration of nociceptive signals or secondary responses to nociceptive signals (ocular, facial, autonomic or behavioral responses). Pain has been studied extensively with fMRI. Several other methods have been proposed: pain behavior, pupillary responses, and autonomic responses.

Somatosensory evoked electrical potentials (SSEP) are routinely recorded to assess the integrity of sensory pathways during spine surgery. Our primary study aim is to correlate the neuronal (EEG) signal (Y1) and/or γ - band power (Y2) with both the stimulus intensity (X1, the voltage of constant current stimulator output) and the perceived pain intensity (X2)

This is a pilot study to test the hypothesis that the gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.

.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quantitative SSEP and EEG as Objective Pain Biomarker
• Actual Study Start Date: May 22, 2018
• Actual Primary Completion Date: November 14, 2019
• Estimated Study Completion Date: February 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standard EEG or SSEP; the intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.	Other: Standard EEG or SSEP; The gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.

Outcome Measures

Primary Outcome Measures :

1. Correlation of (electrical) pain intensity (X) and amplitude of SSEP (Y). [ Time Frame: 20 minutes during the study session (once). ]
   Pearson Correlation of X and Y.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adult human volunteers (age > 18) that are able to understand study procedures.

Exclusion Criteria:

• Medical conditions that would interfere with somatosensory processing. (diabetic neuropathy, stroke), chronic pain, medications known to affect pain processing (opioid therapy, selective serotonin reuptake inhibitor (SSRI)).

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Michael Froelich, MD; UAB Department of Anesthesiology, Critical Care Division

More Information

• Responsible Party: Michael Froelich, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03495180
• Other Study ID Numbers: 67890123
• First Posted: April 11, 2018
• Last Update Posted: March 7, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No