Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?

COVID19 Effects on the Brain and Cerebral Function; Do Quantitative Measures of Brain Electrical Activity Along With Neurocognitive Assessments Correlate With Symptoms and Clinical Assessment?

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Brainscope modified EEG and cognitive testing

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Patients with COVID who are NOT experiencing altered mental status	Diagnostic test: Brainscope modified EEG and cognitive testing; Modified EEG performed using BrainScope device along with cognitive testing performed with BrainScope device and other surveys.
COVID patients; COVID patients who are experiencing confusion,	Diagnostic test: Brainscope modified EEG and cognitive testing; Modified EEG performed using BrainScope device along with cognitive testing performed with BrainScope device and other surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and follow-up evaluations (45-60 days after hospital discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence of neurocoginitive dysfunction over time	Comparison of neurocognitive test results at baseline and follow-up visits	Baseline and follow-up evaluations (45-60 days after hospital discharge)

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Collaborators: BrainScope Company, Inc.
• Investigators: Principal Investigator: Edward Michelson, MD, Chair, Dept of Emergency Medicine; TTUHSC El Paso

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; altered mental status; "brain fog"
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: E22060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No