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OpenTrials
Completed

NCT Number: NCT02796625

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.

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Key information

Age range

21 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Painful Stimuli

Other

warm or painful heat administration

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Purdue Pharma LP

Registry information

Official study title

Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker

Acronym: APB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2016
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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