Event-Related Potential (ERP) Components in Clinical Diagnosis
A legfontosabb adatok
- Ki végzi
- Boston University
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 148 fő vett részt
- Kezdés
- 2023. márc. 6.
- Befejezés
- 2025. máj. 1.
- A vizsgálat típusa
- Megfigyeléses, 4 csoport
- A vizsgált kezelések
- Electroencephalogram (EEG) system
- Standard Neuropsychological Testing
- Additional neuropsychological tests
- A regiszteradat frissítve
- 2025. december 16.
- Miért állt le
- The sponsor stopped funding the study.
Ki vehet részt
- Életkor
- 20 év – 90 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 23 feltétel megnézéseKevesebb
Ki vehet részt
- For Mild Alzheimer Disease (AD) dementia
- Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- 50-90 years old
- Mini-Mental State Examination (MMSE) 20-27
- Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
- Performance on delayed recall and recognition memory worse than 1.5 SD for age \& education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery
- Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses; For Mild cognitive impairment (MCI)
- MCI due to any etiology 50-90 years old
- MMSE > 23
- Performance on delayed recall and recognition memory worse than 1.0 SD for age \& education adjusted norms
- Dr. Turk and Dr. Budson will confirm all MCI diagnoses; For Healthy older adults
- 50-90 years old
- Functioning normally in occupation determined by self-report; For Healthy younger adults
- 20-50 years old
- Functioning normally in occupation determined by self-report
Ki nem vehet részt
- heavy alcohol or drug use
- A clinically significant problem of any of the following conditions:
- cerebrovascular disease
- a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
- any medical condition whose severity could significantly impair cognition (e.g., organ failure)
- on any antipsychotic or epilepsy medication
- depression
- Unable to understand the consent form
Helyszínek itt: Egyesült Államok
- BU Alzheimer Disease CenterBoston, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission.
A teljes eredeti leírásKevesebb
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
A vizsgálat 4 csoportja
- 75 Mild AD
75 patients diagnosed with Mild Alzheimer's disease.
Kezelés: Electroencephalogram (EEG) system és Standard Neuropsychological Testing
- 75 MCI due to any etiology
75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
Kezelés: Electroencephalogram (EEG) system és Standard Neuropsychological Testing
- 25 Healthy Older Adults
25 Healthy older adults age: 50-90 (control).
Kezelés: Electroencephalogram (EEG) system és Standard Neuropsychological Testing
- 25 Healthy Younger Adults
25 Healthy younger adults age: 20-50 (control).
Kezelés: Electroencephalogram (EEG) system, Standard Neuropsychological Testing és Additional neuropsychological tests
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
- A regiszteradat frissítve
- 2025. december 16.