COVID-19NCT05303116
Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?
An observational study of COVID-19, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Brainscope modified EEG and cognitive testing
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with COVID-19 infection who are experiencing 'brain fog' symptoms and who will admitted to the hospital.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center of El Paso
El Paso, Texas, 79905
About this study
Official title: 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.
Read the detailed description
- 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.
- Electroencephalogram (EEG) - We will perform an EEG using a Brainscope device.
- 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.
- 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.
- 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.
- Inventory of COVID Symptoms - Research personnel will collect information about COVID symptoms using standardized PROMIS surveys. (Dyspnea severity and Physical Function)
- 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.
- 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.
- Conditions
- COVID-19
- Being tested
- Brainscope modified EEG and cognitive testing
- Keywords
- COVID-19, "brain fog", altered mental status
- Medical subject headings
- COVID-19, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainscope modified EEG and cognitive testingDiagnostic test
Modified EEG performed using BrainScope device along with cognitive testing performed with BrainScope device and other surveys.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients with COVID who are NOT experiencing altered mental status Receives: Diagnostic Test: Brainscope modified EEG and cognitive testing | |
| COVID patients | COVID patients who are experiencing confusion, Receives: Diagnostic Test: Brainscope modified EEG and cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and follow-up evaluations (45-60 days after hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start21 Apr 2022
- Primary completion19 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- BrainScope Company, Inc.
- Responsible party
- Principal investigator, Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Edward Michelson, MD, Principal investigator, Chair, Dept of Emergency Medicine; TTUHSC El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303116
- Sponsor's protocol ID
- E22060
- Status last verified
- May 2025
- First submitted
- 28 Mar 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 33446327Graham 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 33755344Lambrecq 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.
PubMed 33720371Bazarian 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 33587137Hanley 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 28177169Hanley 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT05303116
- Acronym / sponsor ID
- E22060
- Conditions
- COVID-19
- Keywords
- COVID-19, "brain fog", altered mental status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Collaborators
- BrainScope Company, Inc.
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- Electroencephalogram (EEG) - We will perform an EEG using a Brainscope device.
- 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.
- 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.
- 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.
- Inventory of COVID Symptoms - Research personnel will collect information about COVID symptoms using standardized PROMIS surveys. (Dyspnea severity and Physical Function)
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Brainscope modified EEG and cognitive testingPatients with COVID who are NOT experiencing altered mental status |
| COVID patients | – | Diagnostic Test: Brainscope modified EEG and cognitive testingCOVID patients who are experiencing confusion, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with COVID-19 infection who are experiencing 'brain fog' symptoms and who will admitted to the hospital.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brainscope modified EEG and cognitive testingModified EEG performed using BrainScope device along with cognitive testing performed with BrainScope device and other surveys. | Diagnostic test | COVID patients, Control |
Primary outcome
Identify unique brain electrical activity in patients who have COVID-19 infection and 'brain fog' symptoms
Time frame: Baseline and follow-up evaluations (45-60 days after hospital discharge)
Compile types of EEG changes demonstrated by COVID patients with 'brain fog' symptoms compared to COVID patients without 'brain fog' symptoms.
1 secondary outcome
Persistence of neurocoginitive dysfunction over time
Time frame: Baseline and follow-up evaluations (45-60 days after hospital discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 33446327Maury 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.
- Background: PubMed 33755344Graham 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.
- Background: PubMed 33720371Lambrecq 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.
- Background: PubMed 33587137Bazarian 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.
- Background: PubMed 28177169Hanley 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.
- Background: PubMed 28599608Hanley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Michelson, MD principal investigator
Chair, Dept of Emergency Medicine; TTUHSC El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify unique brain electrical activity in patients who have COVID-19 infection and 'brain fog' symptoms (time frame: Baseline and follow-up evaluations (45-60 days after hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303116, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.