Carbon Monoxide PoisoningNormalEEGNCT02375126
Normal Quantitative EEG (qEEG) Dataset
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
In this study, the investigators will collect EEG data in normal, healthy volunteers without a history of prior brain injury. This data will be analyzed by computer (quantitative, or qEEG) and stored in a normative database so that, in the future, the investigators can better understand and characterize the brain… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Electroencephalography
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2023
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Normal, healthy volunteers (adult men and women, ages 18-55) will be selected from a carefully screened convenience sample.
Who may be able to join
- Men and women, from 18 to 55 years old at the time of study enrollment. Women who are greater than 6 weeks post-partum, who are breastfeeding are allowed to participate if they are able to finish the electroencephalography (EEG) without interruption.
- Able to speak and read English as their primary language.
- Agrees to, and appears able to, participate in all outcome assessments.
- Demonstrates the ability to offer informed consent and signs the study informed consent document.
Who cannot join
- Vulnerable populations including, prisoners, pregnant women, and minors.
- Women who are less than 6 weeks post-partum.
- Unwilling or unable to participate in planned study visits.
- Any past history of brain injury due to trauma, surgery, hypoxia, infection, inflammation, toxicity (e. g., carbon monoxide poisoning), or cerebrovascular etiology.
- Individuals with a diagnosis of, or a persistent history of, or symptoms of a neurological disorder (e.g., tinnitus, vertigo, chronic fatigue, numbness, tingling, chronic migraine, fibromyalgia, multiple sclerosis).
- Currently undergoing therapy for affective disorders, behavioral disorders, or psychological disorders.
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- Diagnosis of post-traumatic stress disorder or sub-clinical post-traumatic stress symptoms.
- Diagnosis of diabetes mellitus, type 1 and type 2.
- Current complaints of brain injury symptoms such as cognitive or affective problems.
- Known neuroimaging abnormalities.
- Participants taking daily prescription drugs or oral over the counter medications beyond vitamins that could impact a normal outcome determined by the Principal Investigator (e.g., beta blockers).
- Participants who are ≥45 may be taking statins or angiotensin converting enzyme (ACE) inhibitors.
- Participants between the ages of 18-55 may be taking antidepressants indicated for depression or post-partum depression.
- Oral or injectable contraceptives are permitted
- Known atrial septal defect, including but not limited to patent foramen ovale.
- History of bypass surgery.
- History of hydrocephalus/microcephaly/macrocephaly.
- History of developmental delay or learning disorder as a child.
- Previous or current use of any illicit drug, at any age.
- Current positive urine drug test for any illicit substance.
- History, by self-report in the last year, of alcohol abuse.
- Current or previous tobacco use, with the exception of minimal use during adolescence.
- Use of any assistive hearing device, or unable to verbally communicate due to hearing loss.
- History, by self-report, of receiving chemotherapy drugs or therapeutic ionizing radiation to the head.
- Foreign material in the head.
- Active malignancy or prior malignancy (except basal cell carcinoma) within the last 5 years.
- Unable to abstain from caffeine products for at least a 2 hour interval.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Healthcare, LDS Hospital
Salt Lake City, Utah, 84143
Rosemary Ziemnik, 801-408-3623, rosemary..ziemnik@imail.org
Lindell K Weaver, MD
About this study
Official title: Normal Quantitative EEG (qEEG) Dataset for the Use in Comparison With Patients Suffering Carbon Monoxide (CO) Poisoning
In this study, the investigators will collect EEG data in normal, healthy volunteers without a history of prior brain injury. This data will be analyzed by computer (quantitative, or qEEG) and stored in a normative database so that, in the future, the investigators can better understand and characterize the brain damage that can result from carbon monoxide (CO) poisoning and other types of brain injury.
Read the detailed description
This is a pilot, prospective, non-comparative, non-invasive, minimal risk research study to obtain qEEG data on normal, healthy individuals to include in a normal control database for use in comparison with patients with CO poisoning and other types of brain injury. The use of anti-depressant medication use is relatively common in the general adult population. There is varying opinion whether anti-depressant medication alters an otherwise normal clinical EEG. We have included healthy individuals taking anti-depressant medication to determine if those medications influence the EEG. The EEG data will be collected, analyzed, and stored for use in future research studies and for clinical care. Evaluating patients with qEEG methodology may assist in diagnosis and treatment.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Electroencephalography
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyProcedure or surgery
Also called EEG
Electroencephalography (EEG) is a relatively inexpensive measurement of basic brain activity. Traditional EEG techniques rely on the clinician to visually examine the electrical current waveforms to identify abnormal signal patterns and slowing. Abnormalities on EEG have been reported following CO poisoning, though the literature is scarce. While current EEG technologies record EEG signals digitally, rather than writing directly to paper, computer-assisted analysis of the data (quantitative EEG, or qEEG) has not been widely embraced, in part because clinicians are unsure what patterns revealed by computer-assisted analysis represent abnormal activity.
| Study group | Role | What they receive |
|---|---|---|
| Ages 18-35, no antidepressant use | Ages 18-35, up to 15 males and 15 females, no antidepressant use Receives: Procedure: Electroencephalography | |
| Ages 36-55, no antidepressant use | Ages 36-55, up to 15 males and 15 females, no antidepressant use Receives: Procedure: Electroencephalography | |
| Ages 18-55, with antidepressant use | Ages 18-55, up to 10 males and 10 females, taking antidepressants Receives: Procedure: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography Completion Questionnaire (Y/N)
Electroencephalography study completed for the participant. (Y/N)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindell K Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375126
- Sponsor's protocol ID
- 1024985
- Acronym
- NormalEEG
- Status last verified
- Aug 2022
- First submitted
- 19 Feb 2015
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Quantitative EEG (qEEG) Dataset for the Use in Comparison With Patients Suffering Carbon Monoxide (CO) Poisoning
- ClinicalTrials.gov ID
- NCT02375126
- Acronym / sponsor ID
- NormalEEG / 1024985
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- 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.
In this study, the investigators will collect EEG data in normal, healthy volunteers without a history of prior brain injury. This data will be analyzed by computer (quantitative, or qEEG) and stored in a normative database so that, in the future, the investigators can better understand and characterize the brain damage that can result from carbon monoxide (CO) poisoning and other types of brain injury.
Detailed description
This is a pilot, prospective, non-comparative, non-invasive, minimal risk research study to obtain qEEG data on normal, healthy individuals to include in a normal control database for use in comparison with patients with CO poisoning and other types of brain injury. The use of anti-depressant medication use is relatively common in the general adult population. There is varying opinion whether anti-depressant medication alters an otherwise normal clinical EEG. We have included healthy individuals taking anti-depressant medication to determine if those medications influence the EEG. The EEG data will be collected, analyzed, and stored for use in future research studies and for clinical care. Evaluating patients with qEEG methodology may assist in diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ages 18-35, no antidepressant use | – | Procedure: ElectroencephalographyAges 18-35, up to 15 males and 15 females, no antidepressant use |
| Ages 36-55, no antidepressant use | – | Procedure: ElectroencephalographyAges 36-55, up to 15 males and 15 females, no antidepressant use |
| Ages 18-55, with antidepressant use | – | Procedure: ElectroencephalographyAges 18-55, up to 10 males and 10 females, taking antidepressants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal, healthy volunteers (adult men and women, ages 18-55) will be selected from a carefully screened convenience sample.
Key inclusion criteria (4 listed)
- Men and women, from 18 to 55 years old at the time of study enrollment. Women who are greater than 6 weeks post-partum, who are breastfeeding are allowed to participate if they are able to finish the electroencephalography (EEG) without interruption.
- Able to speak and read English as their primary language.
- Agrees to, and appears able to, participate in all outcome assessments.
- Demonstrates the ability to offer informed consent and signs the study informed consent document.
Key exclusion criteria (27 listed)
- Vulnerable populations including, prisoners, pregnant women, and minors.
- Women who are less than 6 weeks post-partum.
- Unwilling or unable to participate in planned study visits.
- Any past history of brain injury due to trauma, surgery, hypoxia, infection, inflammation, toxicity (e. g., carbon monoxide poisoning), or cerebrovascular etiology.
- Individuals with a diagnosis of, or a persistent history of, or symptoms of a neurological disorder (e.g., tinnitus, vertigo, chronic fatigue, numbness, tingling, chronic migraine, fibromyalgia, multiple sclerosis).
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 |
|---|---|---|
| ElectroencephalographyAlso: EEGElectroencephalography (EEG) is a relatively inexpensive measurement of basic brain activity. Traditional EEG techniques rely on the clinician to visually examine the electrical current waveforms to identify abnormal signal patterns and slowing. Abnormalities on EEG have been reported following CO poisoning, though the literature is scarce. While current EEG technologies record EEG signals digitally, rather than writing directly to paper, computer-assisted analysis of the data (quantitative EEG, or qEEG) has not been widely embraced, in part because clinicians are unsure what patterns revealed by computer-assisted analysis represent abnormal activity. | Procedure or surgery | Ages 18-35, no antidepressant use, Ages 18-55, with antidepressant use, Ages 36-55, no antidepressant use |
Primary outcome
Electroencephalography Completion Questionnaire (Y/N)
Time frame: Baseline
Electroencephalography study completed for the participant. (Y/N)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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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.
Lindell K Weaver, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. 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 4 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindell K Weaver, MD (801-408-3623, lindell.weaver@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography Completion Questionnaire (Y/N) (time frame: Baseline). 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 10 Aug 2022.