Clinical trial NCT02796625: Alpha as a Predictive Biomarker
Official title: Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: EEG
healthy subjects
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Purdue Pharma LP
First posted: 2016-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Peak Alpha Frequency (Hz)
timeFrame: pain-free and pain states at the baseline visit
Secondary outcomes:
measure: Alpha Wave Activity Reliability
timeFrame: alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
affiliation: University of Maryland Dental School
name: David A Seminowicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: