PainNCT03495180
Quantitative SSEP and EEG As Objective Pain Biomarker
A study testing Standard EEG or SSEP in people with Pain, run by University of Alabama at Birmingham.
Trial summary
Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and chronic pain. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Standard EEG or SSEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2018to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult human volunteers (age > 18) that are able to understand study procedures.
Who cannot join
- Medical conditions that would interfere with somatosensory processing. (diabetic neuropathy, stroke), chronic pain, medications known to affect pain processing (opioid therapy, selective serotonin reuptake inhibitor (SSRI)).
About this study
Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain. And machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.
This is a pilot study to investigate whether components of a person's electrical brain activity do reflect pain sensation.
Read the detailed description
Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and/or chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain and machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.
The establishment of a biomarker of pain is a key requirement for understanding the person-specific effects of anesthetic and analgesic drugs. An objective pain measure will be an integral part in the planning of an anesthetic and potentially enable the researchers to answer the question whether proper matching of the anesthetic or analgesic dose to a person's individual profile will result in better cognitive recovery from anesthesia.
There are several approaches to quantifying pain in an objective fashion. These approaches are based on the observation of afferent signals to the brain, brain integration of nociceptive signals or secondary responses to nociceptive signals (ocular, facial, autonomic or behavioral responses). Pain has been studied extensively with fMRI. Several other methods have been proposed: pain behavior, pupillary responses, and autonomic responses.
Somatosensory evoked electrical potentials (SSEP) are routinely recorded to assess the integrity of sensory pathways during spine surgery. Our primary study aim is to correlate the neuronal (EEG) signal (Y1) and/or γ - band power (Y2) with both the stimulus intensity (X1, the voltage of constant current stimulator output) and the perceived pain intensity (X2)
This is a pilot study to test the hypothesis that the gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.
.
- Conditions
- Pain
- Being tested
- Standard EEG or SSEP
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard EEG or SSEPOther
The gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.
| Study group | Role | What they receive |
|---|---|---|
| Standard EEG or SSEP | Experimental | the intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity. Receives: Other: Standard EEG or SSEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of (electrical) pain intensity (X) and amplitude of SSEP (Y).
Pearson Correlation of X and Y.
Measured: 20 minutes during the study session (once).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start22 May 2018
- Primary completion14 Nov 2019
- Study completion1 Dec 2025 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Froelich, University of Alabama at Birmingham
- Investigators
- Michael Froelich, MD, Principal investigator, UAB Department of Anesthesiology, Critical Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495180
- Sponsor's protocol ID
- 67890123
- Status last verified
- Dec 2024
- First submitted
- 27 Mar 2018
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative SSEP and EEG As Objective Pain Biomarker
- ClinicalTrials.gov ID
- NCT03495180
- Acronym / sponsor ID
- 67890123
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain. And machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.
This is a pilot study to investigate whether components of a person's electrical brain activity do reflect pain sensation.
Detailed description
Over the past few years, significant advances have begun to be made in the development of particular measures as valid biomarkers or surrogate markers for the presence of acute and/or chronic pain. Many of these advances have been made because of the development of new and improved technologies, for example in the fields of imaging and genetics. Research is now showing brain activity and brain organizational changes associated with the presence of pain. Various factors have been found in the blood that is associated with the presence of pain. Research is also suggesting that pupil responses to a variety of stimuli may predict the presence of pain and machine learning analysis of videos has found facial movement patterns in both animals and humans that are correlated with the presence of pain.
The establishment of a biomarker of pain is a key requirement for understanding the person-specific effects of anesthetic and analgesic drugs. An objective pain measure will be an integral part in the planning of an anesthetic and potentially enable the researchers to answer the question whether proper matching of the anesthetic or analgesic dose to a person's individual profile will result in better cognitive recovery from anesthesia.
There are several approaches to quantifying pain in an objective fashion. These approaches are based on the observation of afferent signals to the brain, brain integration of nociceptive signals or secondary responses to nociceptive signals (ocular, facial, autonomic or behavioral responses). Pain has been studied extensively with fMRI. Several other methods have been proposed: pain behavior, pupillary responses, and autonomic responses.
Somatosensory evoked electrical potentials (SSEP) are routinely recorded to assess the integrity of sensory pathways during spine surgery. Our primary study aim is to correlate the neuronal (EEG) signal (Y1) and/or γ - band power (Y2) with both the stimulus intensity (X1, the voltage of constant current stimulator output) and the perceived pain intensity (X2)
This is a pilot study to test the hypothesis that the gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard EEG or SSEP | Experimental | Other: Standard EEG or SSEPthe intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult human volunteers (age > 18) that are able to understand study procedures.
Key exclusion criteria (1 listed)
- Medical conditions that would interfere with somatosensory processing. (diabetic neuropathy, stroke), chronic pain, medications known to affect pain processing (opioid therapy, selective serotonin reuptake inhibitor (SSRI)).
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 |
|---|---|---|
| Standard EEG or SSEPThe gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity. | Other | Standard EEG or SSEP |
Primary outcome
Correlation of (electrical) pain intensity (X) and amplitude of SSEP (Y).
Time frame: 20 minutes during the study session (once).
Pearson Correlation of X and Y.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Michael Froelich, MD principal investigator
UAB Department of Anesthesiology, Critical Care Division
Questions about this trial
What is this clinical trial studying?
A study testing Standard EEG or SSEP in people with Pain, run by University of Alabama at Birmingham.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Correlation of (electrical) pain intensity (X) and amplitude of SSEP (Y). (time frame: 20 minutes during the study session (once).). 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 20 Dec 2024.