Alpha as a Predictive Biomarker

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Painful Stimuli

• Registration Number: NCT02796625
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-13
• Study Start: 2016-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2021-05-04
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Results First Posted: 2021-08-11
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Painful Stimuli	Painful Stimuli	Participants will be exposed to painful heat

Primary Outcome Measures

Name	Time	Method
Peak Alpha Frequency (Hz)	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 Outcome Measures

Name	Time	Method
Alpha Wave Activity Reliability	alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week

Trial Locations

Locations (1)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States