Alpha as a Predictive Biomarker

Pain Clinical Trial

— APB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796625
• Other study ID #: 10017571
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Painful Stimuli
warm or painful heat administration

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Alpha Frequency (Hz)	The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.	pain-free and pain states at the baseline visit
Secondary	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