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Alpha as a Predictive Biomarker (APB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02796625
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : September 23, 2019
Purdue Pharma LP
Information provided by (Responsible Party):
David Seminowicz, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Pain Other: Painful Stimuli Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Painful Stimuli
Participants will be exposed to painful heat
Other: Painful Stimuli
warm or painful heat administration

Primary Outcome Measures :
  1. Alpha Wave Activity [ Time Frame: alpha activity at pain-free and pain states at the baseline visit ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02796625

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United States, Maryland
University of Maryland School of Dentistry
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Purdue Pharma LP
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Principal Investigator: David A Seminowicz, PhD University of Maryland Dental School

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Responsible Party: David Seminowicz, Associate Professor, Department of Neural and Pain Sciences, University of Maryland, Baltimore Identifier: NCT02796625    
Other Study ID Numbers: 10017571
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Seminowicz, University of Maryland, Baltimore:
healthy subjects