N/A
N=80
Alpha as a Predictive Biomarker
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02796625 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Peak Alpha Frequency (Hz) — 10.04 frequency (Hz)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Painful Stimuli (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Alpha Frequency (Hz) |
10.04 | — |
| SECONDARY Alpha Wave Activity Reliability |
.81 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02796625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.