Normal Quantitative EEG (qEEG) Dataset



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/6/2018
Start Date:March 2014
End Date:December 2020
Contact:Lindell K Weaver, MD
Email:lindell.weaver@imail.org
Phone:801-408-3623

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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.

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.

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.
We found this trial at
1
site
Salt Lake City, Utah 84143
Principal Investigator: Lindell K Weaver, MD
Phone: 801-408-3623
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mi
from
Salt Lake City, UT
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