Recruiting

Observational Study

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT02375126

Conditions

Carbon Monoxide Poisoning

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Electroencephalography

Study Details

Brief 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 damage that can result from carbon monoxide (CO) poisoning and other types of brain injury.

Conditions

Carbon Monoxide Poisoning

Study ID

NCT02375126

Start date

Mar, 2014

Status verified date

Aug, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Ages 18-35, no antidepressant use

Ages 18-35, up to 15 males and 15 females, no antidepressant use

Ages 36-55, no antidepressant use

Ages 36-55, up to 15 males and 15 females, no antidepressant use

Ages 18-55, with antidepressant use

Ages 18-55, up to 10 males and 10 females, taking antidepressants

Interventions

Electroencephalography

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.

Primary outcome measure

  • Electroencephalography Completion Questionnaire (Y/N) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Lindell K Weaver, MD

801-408-3623lindell.weaver@imail.org

Locations

Intermountain Healthcare, LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Contacts

Rosemary Ziemnik

801-408-3623rosemary..ziemnik@imail.org

Principal Investigator:

Lindell K Weaver, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Aug 10, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2022-08-10.