Quantitative SSEP and EEG As Objective Pain Biomarker

NCT ID: NCT03495180

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2025-12-01

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.

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.

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Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard EEG or SSEP

the intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.

Group Type: EXPERIMENTAL

Standard EEG or SSEP

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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)).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michael Froelich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Froelich, MD

Role: PRINCIPAL_INVESTIGATOR

UAB Department of Anesthesiology, Critical Care Division

Countries

United States

Other Identifiers

67890123

Identifier Type: -

Identifier Source: org_study_id