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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

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Alpha Wave Activity [ Time Frame: alpha activity at pain-free and pain states at the baseline visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796625 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Alpha as a Predictive Biomarker
Official Title  ICMJE Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE Other: Painful Stimuli
warm or painful heat administration
Study Arms  ICMJE Experimental: Painful Stimuli
Participants will be exposed to painful heat
Intervention: Other: Painful Stimuli
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02796625
Other Study ID Numbers  ICMJE 10017571
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Seminowicz, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Purdue Pharma LP
Investigators  ICMJE
Principal Investigator: David A Seminowicz, PhD University of Maryland Dental School
PRS Account University of Maryland, Baltimore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP