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Neuropsychiatrické postakutní následky SARS-CoV-2 (PASC) pomocí TSPO pozitronové emisní tomografie (PET) a MRI

29. září 2026 aktualizováno: NYU Langone Health

Hodnocení imunologické a vaskulární dysfunkce u neuropsychiatrických postakutních následků SARS-CoV-2 (PASC) pomocí TSPO PET a MRI

The overarching goal of this study is to develop PET/MR techniques for the diagnosis of neuropsychiatric post-acute sequelae (PASC) of SARS-CoV-2. The central hypothesis is that immunological and cerebrovascular dysfunction after acute SARS-CoV-2 infections mediate neuropsychiatric PASC (NP-PASC).

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

30

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • New York
      • New York, New York, Spojené státy, 10016
        • NYU Langone Health

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 50 let (Dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The population will include neuropsychiatric PASC patients, as well as patients with a history of SARS-CoV-2 but no NP-PASC. Potential participants may be directly identified, referred through the ongoing PASC projects at NYU Neurology, identified by the NYU Radiology research coordinators, or recruited via ads. Recruitment will strive to match the two groups in age, sex and BMI.

Popis

Inclusion Criteria:

  • Neuropsychiatric symptoms are defined as respectively a) objective cognitive dysfunction on bedside cognitive testing (ACE-III (Addenbrooke's Cognitive Examination III) =< 86/100, at least 12th grade educational level), and/or b) anxiety, depression or psychotic illness as indicated by the DSM-5 diagnostic criteria, evaluated with the MINI (Mini International Psychiatric Interview) or SCID-5 (Structured Clinical Interview for DSM-5 Disorders, Research Version). It is expected some patients may fall into both categories (cognitive and psychiatric complications), in which case they will be included in this study.
  • Infection with SARS-CoV-2 (3-12 months before study) will be verified based on positive PCR test results provided by the NYU EMR or subject records. Investigators will further record the clinical history and perform nucleoprotein- and spike-antibody testing. Anecdotal evidence shows that anti-nucleoprotein and anti-spike tests will be positive in individuals who had past SARS-CoV-2 infection, but only anti-spike tests will be positive in individuals who were vaccinated but did not have past infection, unless the infected individual has already lost the antibodies due to natural infection .
  • Able to sign informed consent as evaluated by the UCSD Brief Assessment of Capacity to Consent (UBACC) test.

Subgroup Inclusion Criteria

  • NP-PASC subjects will have new onset a) cognitive and/or b) psychiatric symptoms following SARS-CoV-2 infection.
  • CC will have a history of SARS-CoV-2 infection but will not meet the criteria for any DSM-5 diagnosis and will perform within normal limits on cognitive tests.

Exclusion Criteria:

  • If vaccinated for SARS-CoV-2, at least 3 months past the last vaccine administration.
  • Subjects with suicidal ideation who require inpatient or intensive level of care, as determined by a study clinician (Dr. Frankle or Dr. Iosifescu) based on the answers to the screening interview. These patients will be immediately referred to appropriate clinical treatment.
  • Pregnant women or those who become pregnant as determined by a urine test at the time of the blood test and on the day of the PET/MR scan.
  • Obese individuals (BMI >= 30) and individuals with cardiovascular risk factors (e.g., uncontrolled high blood pressure, hypercholesterolemia, current tobacco smokers or smoking in the last 12 months, diabetes mellitus).
  • Individuals with history of serious or unstable medical illness associated with chronic inflammation other than PASC (e.g., rheumatoid arthritis, SLE, etc).
  • Current traumatic brain injury. Subjects with a history of chronic pre-existing neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc), i.e. neurological symptoms should be new onset for inclusion. Patients with substance use disorders, including alcohol, active within the last 12 months.
  • Clinical or laboratory evidence of hypothyroidism. A thyroid stimulating hormone (TSH) test will be drawn in blood, and the patient will be excluded if TSH is abnormal.
  • Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding baseline.
  • Subjects who had recently taken psychotropic medications will be scanned only after a period greater than five half-lives since the last dose of their psychotropic medication. Subjects who choose to start treatment (with psychotropic medication) for their symptoms immediately will thus be excluded.
  • Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
  • Contraindications for Gadolinium-based MRI contrast (allergies to contrast agents and kidney health)
  • Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits of 5 rem per 12 months as confirmed by the Radiation safety questionnaire.
  • If CSF sampling: contraindication for a lumbar puncture (i.e. intracranial mass, bleeding diathesis, spinal developmental anomalies, or local skin infection involving the lower back). Complete blood count and coagulation studies will be drawn, and if abnormal (INR>1.3, platelets less than 100), subjects will be able to complete imaging studies but will not be eligible for the lumbar puncture procedure part of the study.
  • Unable to sign informed consent or to comply with study assessments.
  • Urine will be collected for toxicology screening (amphetamine, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine/PCP, THC, and tricyclic antidepressants). Subjects in whom THC is found will be scanned only after abstaining for 7 days. A pregnancy test will be performed on all premenopausal women to ensure exclusion criteria are appropriately screened.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: COHORT
  • Časové perspektivy: CROSS_SECTIONAL

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
NP-PASC (neuropsychiatric post-acute sequelae of SARS-CoV-2)

Individuals with new onset a) cognitive and/or b) psychiatric symptoms following SARS-CoV-2 infection. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample.

Standard radiopharmaceutical injected via intravenous catheter during PET-MR scanning.

Ostatní jména:
  • C11-ER176

Injected via intravenous catheter during PET-MR scanning.

Ostatní jména:
  • Kontrastní látka na bázi gadolinia (GBCA)

Used to evaluate neuroinflammation and cerebrovascular measures. Some MRI image acquisitions will employ work in progress (WIP) sequences, including ASL (Arterial Spin Labeling), Diffusion and T2-weighted EPI (DT2W), Golden-angle radial sparse parallel (GRASP) DCE-MRI, and Magnetization Transfer (MT) imaging.

CC (COVID Control)

Individuals with a history of SARS-CoV-2 infection who do not meet the criteria for any DSM-5 diagnosis and perform within normal limits on cognitive tests. Participants will undergo PET/MR scanning, during which a TSPO PET tracer and a Gadolinium-based MRI tracer will be administered intravenously and blood samples will be collected from an arterial line. In addition, blood samples will be taken at screening. Participants can elect to provide an optional cerebrospinal fluid (CSF) sample.

Standard radiopharmaceutical injected via intravenous catheter during PET-MR scanning.

Ostatní jména:
  • C11-ER176

Injected via intravenous catheter during PET-MR scanning.

Ostatní jména:
  • Kontrastní látka na bázi gadolinia (GBCA)

Used to evaluate neuroinflammation and cerebrovascular measures. Some MRI image acquisitions will employ work in progress (WIP) sequences, including ASL (Arterial Spin Labeling), Diffusion and T2-weighted EPI (DT2W), Golden-angle radial sparse parallel (GRASP) DCE-MRI, and Magnetization Transfer (MT) imaging.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Level of Translocator Protein (TSPO)
Časové okno: PET/MR Visit (Day 1)

Binding of PET tracer to TSPO.

PET/MR Visit (Day 1)
Occurrence of Microhemorrhages
Časové okno: PET/MR Visit (Day 1)

Evaluated using MRI images (Susceptibility Weighted MRI (SWI), Fluid Attenuated Inversion Recovery (FLAIR), Diffusion Weighted Imaging (DWI), and anatomical MRI).

PET/MR Visit (Day 1)
Permeability Surface Area Product (PS)
Časové okno: PET/MR Visit (Day 1)

Used to evaluate disruptions in the blood-brain-barrier. Derived from the DCE-MRI.

PET/MR Visit (Day 1)
Cerebral Blood Flow
Časové okno: PET/MR Visit (Day 1)

Evaluated using cerebral blood flow maps from Arterial Spin Labeling (ASL).

PET/MR Visit (Day 1)
Peripheral Levels of Pro-Inflammatory Cytokines
Časové okno: PET/MR Visit (Day 1)

Evaluated using blood samples.

PET/MR Visit (Day 1)
Peripheral Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Časové okno: PET/MR Visit (Day 1)

Evaluated using blood samples.

PET/MR Visit (Day 1)
CSF Levels of Pro-Inflammatory Cytokines
Časové okno: CSF Visit (Screening) (Optional)

Evaluated using cerebrospinal fluid collection (optional procedure).

CSF Visit (Screening) (Optional)
CSF Levels of High-Sensitivity C-reactive Protein (hs-CRP)
Časové okno: CSF Visit (Screening) (Optional)

Evaluated using cerebrospinal fluid collection (optional procedure).

CSF Visit (Screening) (Optional)
Free Diffusing Water Fraction
Časové okno: PET/MR Visit (Day 1)

Calculated using DWI.

PET/MR Visit (Day 1)
Extra-Axonal Water Fraction
Časové okno: PET/MR Visit (Day 1)

Calculated using DWI.

PET/MR Visit (Day 1)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Steven Baete, NYU Langone Health

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. února 2022

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

7. listopadu 2022

První předloženo, které splnilo kritéria kontroly kvality

7. listopadu 2022

První zveřejněno (Aktuální)

14. listopadu 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 21-00945

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Steven.baete@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Časový rámec sdílení IPD

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Kritéria přístupu pro sdílení IPD

Requests should be directed to Steven.baete@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

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