Alpha as a Predictive Biomarker

NCT02796625 | Completed Results

• 1 other identifier: 10017571
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

EEG; healthy subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Painful Stimuli

EXPERIMENTAL

Participants will be exposed to painful heat

Other: Painful Stimuli

Interventions

Painful Stimuli OTHER

warm or painful heat administration

Painful Stimuli

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Purdue Pharma LP: collaborator

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Seminowicz
• Organization: University of Maryland Baltimore

dseminowicz@umaryland.edu

14107063476

Study Officials

• David A Seminowicz, PhD

  University of Maryland Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Neural and Pain Sciences

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 13, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)