Normal Quantitative EEG (qEEG) Dataset

NCT02375126 | Unknown

• 1 other identifier: 1024985
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Electroencephalography Completion Questionnaire (Y/N)

  Electroencephalography study completed for the participant. (Y/N)

  Baseline

Study Arms (3)

Ages 18-35, no antidepressant use

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

Procedure: Electroencephalography

Ages 36-55, no antidepressant use

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

Procedure: Electroencephalography

Ages 18-55, with antidepressant use

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

Procedure: Electroencephalography

Interventions

Electroencephalography PROCEDURE

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.

Also known as: EEG

Ages 18-35, no antidepressant use; Ages 18-55, with antidepressant use; Ages 36-55, no antidepressant use

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Normal, healthy volunteers (adult men and women, ages 18-55) will be selected from a carefully screened convenience sample.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Healthcare, LDS Hospital

Salt Lake City, Utah, 84143, United States

RECRUITING

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Lindell K Weaver, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindell K Weaver, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (1)