Trial Outcomes & Findings for Alpha as a Predictive Biomarker (NCT NCT02796625)

Results Overview

The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

pain-free and pain states at the baseline visit

Results posted on

2021-08-11

Participant milestones
Measure	Painful Stimuli Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Overall Study STARTED	80
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	19

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Painful Stimuli n=61 Participants Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Age, Categorical <=18 years	0 Participants n=61 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=61 Participants
Age, Categorical >=65 years	0 Participants n=61 Participants
Age, Continuous	27.8 years n=61 Participants
Sex: Female, Male Female	30 Participants n=61 Participants
Sex: Female, Male Male	31 Participants n=61 Participants
Region of Enrollment United States	61 participants n=61 Participants

Timeframe: pain-free and pain states at the baseline visit

Population: all participants with valid data

The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.

Outcome measures
Measure	Painful Stimuli n=61 Participants Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Peak Alpha Frequency (Hz)	10.04 frequency (Hz) Standard Deviation 0.20

Timeframe: 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

Outcome measures
Measure	Painful Stimuli n=43 Participants Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Alpha Wave Activity Reliability	.81 Spearman rho

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Maryland Baltimore

Phone: 14107063476