Quantitative SSEP and EEG As Objective Pain Biomarker

NCT03495180 | Withdrawn DMC

• 1 other identifier: 67890123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Correlation of (electrical) pain intensity (X) and amplitude of SSEP (Y).

  Pearson Correlation of X and Y.

  20 minutes during the study session (once).

Study Arms (1)

Standard EEG or SSEP

EXPERIMENTAL

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

Other: Standard EEG or SSEP

Interventions

Standard EEG or SSEP 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.

Standard EEG or SSEP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Froelich, MD

  UAB Department of Anesthesiology, Critical Care Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 11, 2018
• Study Start: May 22, 2018
• Primary Completion: November 14, 2019
• Study Completion: December 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12