Brain fog due to post - COVID syndrome Brain fog, fatigue,cognitive dysfunction
Conditions
Interventions
To administer perampanel
Sponsors
Eiro Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and Female aged 20 to under 60 at the time of consent acquisition. 2. Individuals confirmed to have been diagnosed with SARS-CoV-2 infection by a physician based on clinical findings such as fever or upper respiratory symptoms, or those confirmed positive for SARS-CoV-2 infection through PCR or antigen testing at a medical institution. 3. Individuals whose cognitive sequelae have persisted for more than two months after infection and who, at the time of consent acquisition, continue to experience symptoms that interfere with work, study, or daily life. 4. Individuals scoring 85 or below on the age-adjusted RBANS neuropsychological test (mean score of 100, standard deviation of 15) or scoring below the average -1SD on index scores (subcategories). 5. Individuals deemed to have sufficient capacity for consent judgment based on evaluation using the MacArthur Competence Assessment Tool (MacCAT), and who have provided written consent to participate in this study, or for whom written consent has been obtained from a proxy.
Exclusion criteria
Exclusion criteria: 1. Individuals who are pregnant, breastfeeding, or wish to become pregnant during the study participation period. 2. Individuals confirmed to have a blood hCG level of 6 mIU/ml or higher. 3. Individuals who are hypersensitive to alcohol. 4. Individuals whose blood tests show any of AST, ALT, or ALP levels more than 2.5 times the upper limit of the institutional normal range, or whose serum Cr is 2.0 mg/dl or higher. 5. Individuals diagnosed with epilepsy at any time before or after SARS-CoV-2 infection. 6. Individuals diagnosed with psychiatric disorders at any time before or after SARS-CoV-2 infection. 7. Individuals diagnosed with neurological disorders at any time before or after SARS-CoV-2 infection. 8. Individuals diagnosed with substance-related disorders (excluding disorders caused by nicotine or caffeine) at any time before or after SARS-CoV-2 infection. 9. Individuals confirmed to have tested positive for dependent substances (excluding medications taken for treatment) in a urine screening test. 10. Individuals who require continuous use of perampanel or topiramate. 11. Individuals unsuitable for 3-Tesla MRI scanning (e.g., those with implanted metal incompatible with 3-Tesla MRI, tattoos larger than a single point including cosmetic tattoos, severe claustrophobia, or body size incompatible with the MRI scanner). 12. Individuals who may receive unapproved treatments or examinations in other clinical trials or research studies during this study participation period. 13. Any other individuals judged unsuitable for participation by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of the occurrence of adverse events (type, frequency, severity, and relationship to the investigational drug). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) RBANS scores at screening and Day 56 (2) EQ-5D-5L scores at screening and Day 56 (3) The presence or absence of brain regions showing significant changes (decrease or increase) in AMPA receptor density (SUVRWB) detected through voxel-wise analysis of [11C]K-2 PET brain imaging data before and after perampanel administration. | — |
Contacts
Public ContactAkane Sano
Yokohama city university, school of medicine
Outcome results
None listed