Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?

NCT05303116 | Completed FDA Device

• 1 other identifier: E22060
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; "brain fog"; altered mental status

Outcome Measures

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.

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

Secondary Outcomes (1)

• Persistence of neurocoginitive dysfunction over time

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

Study Arms (2)

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

Brainscope modified EEG and cognitive testing DIAGNOSTIC_TEST

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

COVID patients; Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead
• BrainScope Company, Inc.: collaborator

Study Sites (1)

University Medical Center of El Paso

El Paso, Texas, 79905, United States

Location

Related Publications (6)

• 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.

  PMID: 33446327 BACKGROUND

• 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.

  PMID: 33755344 BACKGROUND

• 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.

  PMID: 33720371 BACKGROUND

• 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.

  PMID: 33587137 BACKGROUND

• 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.

  PMID: 28177169 BACKGROUND

• 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.

  PMID: 28599608 BACKGROUND

MeSH Terms

Conditions

COVID-19; Mental Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Edward Michelson, MD

  Chair, Dept of Emergency Medicine; TTUHSC El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Dept of Emergency Medicine

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: March 31, 2022
• Study Start: April 21, 2022
• Primary Completion: February 19, 2024
• Study Completion: February 20, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)