PainAPBNCT02796625
Alpha as a Predictive Biomarker
A study testing Painful Stimuli in people with Pain, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Painful Stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Painful Stimuli
- Keywords
- EEG, healthy subjects
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Painful StimuliOther
warm or painful heat administration
| Study group | Role | What they receive |
|---|---|---|
| Painful Stimuli | Experimental | Participants will be exposed to painful heat Receives: Other: Painful Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pain-free and pain states at the baseline visit
Secondary outcomes (1)
Alpha Wave Activity Reliability
Measured: alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue Pharma LP
- Responsible party
- Principal investigator, David Seminowicz, University of Maryland, Baltimore
- Investigators
- David A Seminowicz, PhD, Principal investigator, University of Maryland Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796625
- Sponsor's protocol ID
- 10017571
- Acronym
- APB
- Status last verified
- Jul 2021
- First submitted
- 25 May 2016
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker
- ClinicalTrials.gov ID
- NCT02796625
- Acronym / sponsor ID
- APB / 10017571
- Conditions
- Pain
- Keywords
- EEG, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Purdue Pharma LP
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 11 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Painful Stimuli | Experimental | Other: Painful StimuliParticipants will be exposed to painful heat |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Painful Stimuliwarm or painful heat administration | Other | Painful Stimuli |
Primary outcome
Peak Alpha Frequency (Hz)
Time frame: 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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Seminowicz, PhD principal investigator
University of Maryland Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Painful Stimuli in people with Pain, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Alpha Frequency (Hz) (time frame: pain-free and pain states at the baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.