Alpha as a Predictive Biomarker (APB)
July 19, 2021 updated by: David Seminowicz, University of Maryland, Baltimore
Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland School of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Painful Stimuli
Participants will be exposed to painful heat
|
warm or painful heat administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Alpha Frequency (Hz)
Time Frame: pain-free and pain states at the baseline visit
|
The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.
|
pain-free and pain states at the baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Alpha Wave Activity Reliability
Time Frame: alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week
|
alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David A Seminowicz, PhD, University of Maryland Dental School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
May 25, 2016
First Submitted That Met QC Criteria
June 6, 2016
First Posted (Estimate)
June 13, 2016
Study Record Updates
Last Update Posted (Actual)
August 11, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10017571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.