Alpha as a Predictive Biomarker

NCT ID: NCT02796625

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-07-31

Brief Summary

The investigators will use non-invasive recordings of brain activity to measure pain as a proxy to self-report. Participants will undergo testing for about 3 hours on two separate days. The testing will involve experiencing painful heat.

Detailed Description

Neurophysiological investigations of pain have suggested that electroencephalograph (EEG) measures of peak alpha frequency might provide a means of pain assessment. In healthy subjects, increased peak alpha frequency is strongly correlated with pain self-reports after exposure to acute noxious heat. Conversely, chronic pain patients compared to healthy control display decreased peak alpha frequencies higher in alpha power. Measures of peak alpha frequency also show a negative relationship with disease duration, suggesting that peak alpha frequency may not only index ongoing pain but also disease progression. The overall aim is to determine the predictive accuracy, reliability, and specificity of EEG alpha activity in acute pain and a model of neuropathic pain in healthy subjects.

Conditions

Pain

Study Design

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

Study Groups

Painful Stimuli

Participants will be exposed to painful heat

Group Type: EXPERIMENTAL

Painful Stimuli

Intervention Type: OTHER

warm or painful heat administration

Interventions

Painful Stimuli

warm or painful heat administration

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Able to speak, read, and write English
• Between 21 and 44 years of age
• Able to understand and willing to comply with all study procedures and is available for the duration of the study
• Free of an acute or chronic pain condition
• Not history of psychiatric or neurologic condition

Exclusion Criteria

• Unable to undergo EEG, assessed on an individual basis
• History of unstable major psychiatric disorder (self-report)
• History of chronic pain (self-report)
• More than 14 alcoholic drinks per week on average (self-report)
• Active [within 6 months] substance or alcohol abuse (self-report and urine toxicology)
• Use of opioids (self-report and urine toxicology)
• History of major depressive disorder (self-report)
• Pregnant or Lactating (women only), based on (self-report and urine test)
• Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
• Uncontrolled (systolic blood pressure > 175 mmHg or diastolic blood pressure >105 mmHg) or unstable hypertension

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

David Seminowicz

Associate Professor, Department of Neural and Pain Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Seminowicz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Dental School

Locations

University of Maryland School of Dentistry

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10017571

Identifier Type: -

Identifier Source: org_study_id