Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms? (NCT05303116) | Clinical Trial Compass
CompletedNot Applicable
Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?
United States55 participantsStarted 2022-04-21
Plain-language summary
Since the neurologic symptoms of some COVID patients ('brain fog') resemble those of patients with concussion, the aim of this study is to identify EEG and cognitive function changes in COVID patients. We will use the FDA cleared BrainScope medical device in conjunction with standard neurocognitive tests to identify correlations with electrical biomarkers and to potentially identify new, unique patterns of altered brain electrical activity associated with COVID-19 infection. A baseline assessment will be performed shortly after hospital presentation and then a second evaluation will be performed 45-60 days post hospital discharge to reassess clinical status, brain electrical biomarkers and neurocognitive performance. The goal will be to develop an objective measurement of brain function/dysfunction associated with COVID-19 infection which might be employed in future studies of treatments for COVID-19 brain fog and to aid in tracking recovery.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Current COVID 19 infection
* Experiencing 'brain fog' symptoms (e.g.confusion, mental slowness, unable to concentrate)
* GCS of 14 or 15
* sufficient mental capacity to provide informed consent
* hemodynamically stable
* able to cooperate with EEG collection and neurometric testing
* admitted to a floor bed rather than ICU
Exclusion Criteria:
* Head or facial trauma
* Any abnormality that would prevent electrodes from being placed on the head
* Known central nervous system (CNS) disease i.e. MS, Parkinson's disease
* Know seizure disorder
* Known dementia
* Metabolic encephalopathy i.e. uremia, hepatic
* Alcohol intoxication to the point they cannot give consent
* Hypoxia that is not corrected to 92% by nasal cannula, or simple face mask
* Chronic alcohol or drug dependence
* Prior cerebrovascular accident (CVA)
* Prior brain surgery
* Known brain mass
* Receiving sedation medications at time of consent
* End stage renal disease (ESRD) on dialysis
* Acute psychosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify unique brain electrical activity in patients who have COVID-19 infection and 'brain fog' symptoms
Timeframe: Baseline and follow-up evaluations (45-60 days after hospital discharge)
Trial details
NCT IDNCT05303116
SponsorTexas Tech University Health Sciences Center, El Paso