An interventional study of Painful Stimuli in Pain, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 21 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Basic science
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.
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be exposed to painful heat
Other: Painful Stimuli
warm or painful heat administration
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
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
| Milestone | Painful Stimuli |
|---|---|
| Started | 80 |
| Completed | 61 |
| Not completed | 19 |
The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.
| frequency (Hz) | Painful Stimuli |
|---|---|
| Peak Alpha Frequency (Hz) | 10.04 ± 0.20 |
| Spearman rho | Painful Stimuli |
|---|---|
| Alpha Wave Activity Reliability | .81 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Painful Stimuli | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Age, Categorical(Participants) | Painful Stimuli |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 61 |
| >=65 years | 0 |
| Age, Continuous(years) | Painful Stimuli |
|---|---|
| Mean | 27.8 (21 to 42) |
| Sex: Female, Male(Participants) | Painful Stimuli |
|---|---|
| Female | 30 |
| Male | 31 |
| Race and Ethnicity Not Collected(Participants) | Painful Stimuli |
|---|
| Region of Enrollment(participants) | Painful Stimuli |
|---|---|
| United States | 61 |
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Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore