APB: Alpha as a Predictive Biomarker

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT02796625
• Collaborator: Purdue Pharma LP (Industry)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Painful Stimuli	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Painful Stimuli Participants will be exposed to painful heat	Other: Painful Stimuli; warm or painful heat administration

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 44 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland School of Dentistry	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore
• Purdue Pharma LP

Investigators

• Principal Investigator: David A Seminowicz, PhD, University of Maryland Dental School

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 6, 2018

More Information

Publications

None provided.

• Responsible Party: David Seminowicz, Associate Professor, Department of Neural and Pain Sciences, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT02796625
• Other Study ID Numbers: 10017571
• First Posted: Jun 13, 2016
• Last Update Posted: Aug 11, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Seminowicz, Associate Professor, Department of Neural and Pain Sciences, University of Maryland, Baltimore: EEG; healthy subjects

Study Results

Participant Flow

Arm/Group Title	Painful Stimuli
Arm/Group Description	Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Period Title: Overall Study
STARTED	80
COMPLETED	61
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Painful Stimuli
Arm/Group Description	Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Overall Participants	61
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	61 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	27.8
Sex: Female, Male (Count of Participants)
Female	30 49.2%
Male	31 50.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	61 100%

Outcome Measures

1. Primary Outcome

Title	Peak Alpha Frequency (Hz)
Description	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

Outcome Measure Data

Analysis Population Description

all participants with valid data

Arm/Group Title	Painful Stimuli
Arm/Group Description	Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Measure Participants	61
Mean (Standard Deviation) [frequency (Hz)]	10.04 (0.20)

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Participants with data at visits 1 and 2

Arm/Group Title	Painful Stimuli
Arm/Group Description	Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
Measure Participants	43
Number [Spearman rho]	.81

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Painful Stimuli
Arm/Group Description	Participants will be exposed to painful heat Painful Stimuli: warm or painful heat administration
All Cause Mortality
	Painful Stimuli
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Serious Adverse Events
	Painful Stimuli
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Other (Not Including Serious) Adverse Events
	Painful Stimuli
	Affected / at Risk (%)	# Events
Total	0/61 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.