Pain
Conditions
Keywords
EEG, healthy subjects
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.
Interventions
OTHERPainful Stimuli
warm or painful heat administration
Sponsors
Purdue Pharma LP
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Painful Stimuli Participants will be exposed to painful heat
Painful Stimuli: warm or painful heat administration | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Painful Stimuli | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 61 Participants | — |
| Age, Continuous | 27.8 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 61 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
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.
Time frame: pain-free and pain states at the baseline visit
Population: all participants with valid data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Painful Stimuli | Peak Alpha Frequency (Hz) | 10.04 frequency (Hz) | Standard Deviation 0.2 |
Secondary
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
Population: Participants with data at visits 1 and 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Painful Stimuli | Alpha Wave Activity Reliability | .81 Spearman rho |