Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT05303116
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do EEG and Neurocognitive Assessments Correlate With COVID Brainfog Symptoms?
Sponsor:
Texas Tech University Health Sciences Center, El Paso
Organization:
Study Overview
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?
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: