ClinicalTrials.gg
CompletedNCT05303116Updated May 18, 2025

Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?

An observational study in COVID-19, sponsored by Texas Tech University Health Sciences Center, El Paso. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Texas Tech University Health Sciences Center, El Paso · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,858 studies in COVID-19 with a site in United States — 120 open to participants now, 209 under way, 16 of them phase 3. COVID-19 · United States.

Enrollment
419th of 521
55 · median 300
Started
2022
with 222 others
Observational
521 of 1,858
52 open now
Registered
1,427th of 1,858
by date

Among the 1,858 studies in COVID-19 with a site in United States, this one is the 419th largest by enrollment of the 521 observational ones that give a count, is one of 223 that started in 2022, is one of 521 observational ones, and was the 1,427th registered.

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

120 of the 1,858 studies in COVID-19 with a site in United States are open now. Recruiting first, the newest first:

115 more — sign in →

All 120 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description
  1. Screening and Consent - Patients with a diagnosis of COVID-19 will be asked by the research personnel if they are experiencing symptoms of 'brain fog' (confusion, altered memory, headache, trouble concentrating.) Those responding affirmatively will be asked to complete a brief mental status exam (mini MoCA). Those patients scoring 25 or less out of 30 will then move forward to the formal written consent process. We will also recruit 5 control patients who are COVID positive but are not experiencing 'brainfog' symptoms.
  2. Electroencephalogram (EEG) - We will perform an EEG using a Brainscope device.
  3. Neurocognitive Assessment (brain function tests) - While the EEG electrodes are still attached, we will perform these assessments that test attention, concentration, reaction time, processing speed, decision making, and executive function. These are called the Structural Injury classifier (SIC) and Concussion Index (CI) assessments that are computed using FDA cleared algorithms for the likelihood of structural brain injury and the likelihood and severity of brain function impairment.
  4. Full MoCA assessment - After the Brainscope evaluation patients will be asked questions on the paper-based full MoCA cognitive assessment and the score will be recorded.
  5. Concussion Symptom Inventory (CSI) - Study personnel will ask questions about symptoms using the CSI which is a standardized tool for evaluating injured patients who have concussion.
  6. Inventory of COVID Symptoms - Research personnel will collect information about COVID symptoms using standardized PROMIS surveys. (Dyspnea severity and Physical Function)
  7. Demographics - We will collect demographic information that includes age and sex, along with vital signs, pulse oximetry, and supplemental oxygen requirement, physical exam, neurological exam, lab test results, medications given during hospitalization, and results of any imaging done on the head during hospitalization. Standard laboratory results including blood counts, chemistry and biomarkers of inflammation obtained as standard of care will be recorded.
  8. Follow-up Visit - Participants will return to the clinic for a follow-up visit 45-60 days after discharge from the hospital. At that visit the Brainscope EEG, mental function tests, and symptom surveys will be repeated.
03

Conditions studied

  • COVID-19

Keywords

  • COVID-19
  • "brain fog"
  • altered mental status
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with COVID-19 infection who are experiencing 'brain fog' symptoms and who will admitted to the hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • hemodynamically stable
  • able to cooperate with EEG collection and neurometric testing
  • admitted to a floor bed rather than ICU

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    Patients with COVID who are NOT experiencing altered mental status

    Diagnostic Test: Brainscope modified EEG and cognitive testing

  • COVID patients

    COVID patients who are experiencing confusion,

    Diagnostic Test: Brainscope modified EEG and cognitive testing

Interventions

  • Diagnostic testBrainscope modified EEG and cognitive testing

    Modified EEG performed using BrainScope device along with cognitive testing performed with BrainScope device and other surveys.

06

What researchers measure

Primary outcomes

  1. Identify unique brain electrical activity in patients who have COVID-19 infection and 'brain fog' symptoms

    Compile types of EEG changes demonstrated by COVID patients with 'brain fog' symptoms compared to COVID patients without 'brain fog' symptoms.

    Time frame: Baseline and follow-up evaluations (45-60 days after hospital discharge)

Secondary outcomes

  1. Persistence of neurocoginitive dysfunction over time

    Comparison of neurocognitive test results at baseline and follow-up visits

    Time frame: Baseline and follow-up evaluations (45-60 days after hospital discharge)

07

Study locations

1 site
  • University Medical Center of El Paso
    EL Paso, Texas 79905, United States
08

References and documents

Publications

  • Maury A, Lyoubi A, Peiffer-Smadja N, de Broucker T, Meppiel E. Neurological manifestations associated with SARS-CoV-2 and other coronaviruses: A narrative review for clinicians. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):51-64. doi: 10.1016/j.neurol.2020.10.001. Epub 2020 Dec 16. PubMed 33446327 ↗
  • Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30. PubMed 33755344 ↗
  • Lambrecq V, Hanin A, Munoz-Musat E, Chougar L, Gassama S, Delorme C, Cousyn L, Borden A, Damiano M, Frazzini V, Huberfeld G, Landgraf F, Nguyen-Michel VH, Pichit P, Sangare A, Chavez M, Morelot-Panzini C, Morawiec E, Raux M, Luyt CE, Rufat P, Galanaud D, Corvol JC, Lubetzki C, Rohaut B, Demeret S, Pyatigorskaya N, Naccache L, Navarro V; Cohort COVID-19 Neurosciences (CoCo Neurosciences) Study Group. Association of Clinical, Biological, and Brain Magnetic Resonance Imaging Findings With Electroencephalographic Findings for Patients With COVID-19. JAMA Netw Open. 2021 Mar 1;4(3):e211489. doi: 10.1001/jamanetworkopen.2021.1489. Erratum In: JAMA Netw Open. 2022 Jun 1;5(6):e2219899. doi: 10.1001/jamanetworkopen.2022.19899. PubMed 33720371 ↗
  • Bazarian JJ, Elbin RJ, Casa DJ, Hotz GA, Neville C, Lopez RM, Schnyer DM, Yeargin S, Covassin T. Validation of a Machine Learning Brain Electrical Activity-Based Index to Aid in Diagnosing Concussion Among Athletes. JAMA Netw Open. 2021 Feb 1;4(2):e2037349. doi: 10.1001/jamanetworkopen.2020.37349. PubMed 33587137 ↗
  • Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones EB, Wright DW, O'Neill J, Badjatia N, Gandhi D, Curley KC, Chiacchierini R, O'Neil B, Hack DC. Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial. Acad Emerg Med. 2017 May;24(5):617-627. doi: 10.1111/acem.13175. Epub 2017 Mar 31. PubMed 28177169 ↗
  • Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley KC, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity Electroencephalographic-Based Biomarker of Functional Impairment in Traumatic Brain Injury: A Multi-Site Validation Trial. J Neurotrauma. 2018 Jan 1;35(1):41-47. doi: 10.1089/neu.2017.5004. Epub 2017 Sep 21. PubMed 28599608 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Feb 2024, 21 months.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 21 months is above that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2022
First posted
Mar 31, 2022
StartActual
Apr 21, 2022
Primary completionActual
Feb 19, 2024
CompletionActual
Feb 20, 2024
Last update
May 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05303116
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborators
BrainScope Company, Inc.
Responsible party
Edward Michelson, MD (Professor and Chair, Dept of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso) — Principal investigator
First posted
Mar 31, 2022
Start date
Apr 21, 2022
Primary completion
Feb 19, 2024
Completion
Feb 20, 2024
Last update
May 18, 2025

Study contacts

Edward Michelson, MD
principal investigator · Chair, Dept of Emergency Medicine; TTUHSC El Paso

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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