Establishing Normal Cognitive Test Scores for Adults Using a Voice-Enabled Digital Testing Platform Across the Lifespan
Establishment of Age-, Sex-, and Education-Stratified Normative Data for a Fully Digital Voice-Recognized Neurocognitive Testing Platform in Adults Aged 18-100 Years
Trial weblink: https://www.memoryexam.com/job/norms/
Participants enrolled in this study will complete a single-session, non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the study is to establish normative cognitive performance data from healthy adults aged 18-100 years and develop age-, sex-, and education-adjusted reference values for the digital assessment platform. This is an observational study and does not involve any therapeutic intervention, investigational treatment, or alteration of routine medical care.
Following electronic informed consent, participants will complete a standardized screening questionnaire to determine eligibility. The questionnaire collects demographic information, education, English language proficiency, medical and neurological history, psychiatric history, medication use, substance use, sleep history, and self-reported cognitive concerns. Standardized mood screening instruments (PHQ-9 and GAD-7) are also administered. Individuals meeting predefined exclusion criteria that could significantly influence cognitive performance will not be included in the normative dataset.
Eligible participants will then complete a digital cognitive assessment battery using standardized visual and auditory instructions. The platform utilizes automated voice-recognition technology to capture spoken responses and standardized algorithms to score performance, eliminating the need for examiner scoring and ensuring consistent administration across participants. Total study participation, including consent, screening, and testing, is approximately 30 to 45 minutes.
The cognitive battery evaluates multiple cognitive domains commonly assessed during neuropsychological examinations. Language abilities are assessed through phonemic and semantic verbal fluency tasks, measuring the ability to rapidly generate words within specified categories. Confrontation naming is evaluated using digitally presented images that participants identify verbally. Learning and memory are assessed through immediate and delayed verbal recall tasks, including recognition memory measures. Attention and working memory are evaluated using forward and backward digit span tasks. Executive functioning and attention are further assessed using a brief computerized problem-solving task. Equivalent alternate versions of selected tasks may be administered to minimize practice effects while measuring the same cognitive domains. All assessments are brief, non-invasive, and completed using spoken responses.
The platform automatically records participant responses, response timing, and scoring metrics. Voice recordings are collected solely to support automated scoring and quality assurance. All electronic data are transmitted using encrypted connections and stored within HIPAA-aligned cloud infrastructure. Personally identifiable information is stored separately from cognitive performance data using unique study identification numbers, and only authorized study personnel have access to identifiable information. De-identified data will be used to generate normative reference values.
A subset of approximately 100 participants may be invited to complete a second assessment 2-4 weeks after the initial visit to evaluate test-retest reliability. Participation in this follow-up assessment is voluntary.
Participants will not receive diagnostic results or individualized interpretations of their performance because the study is intended solely to establish normative reference data. If responses on the PHQ-9 suggest potential acute self-harm risk, the platform will provide crisis resources and notify the study team in accordance with the study safety procedures.
The primary outcome of the study is the development of age-, sex-, and education-adjusted normative reference values for the digital cognitive assessment platform, supporting standardized interpretation of future assessments in clinical and research settings.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Gregory Sahagian, MD
- Telefonnummer: 760-631-3000
- E-post: research@intraneuron.com
Studiesteder
-
-
California
-
Carlsbad, California, Forente stater, 92011
- Rekruttering
- The Neurology Center of Southern California
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 100 years at the time of enrollment.
- Able to read, speak, and understand English sufficiently to complete all study procedures.
- Able and willing to provide informed consent.
- Adequate hearing, speech, and vision (with corrective devices if needed) to complete computerized voice-recognition cognitive testing.
- Able to independently complete the digital cognitive assessment using a computer, tablet, or smartphone with internet access (or at a supervised study site if applicable).
Exclusion Criteria:
- Known Cognitive Impairment Self-reported or previously diagnosed cognitive impairment, memory disorder, mild cognitive impairment, or dementia.
- Neurological Disease or Brain Injury History of a neurological condition or brain injury that, in the opinion of the investigator, may adversely affect cognitive performance.
- Psychiatric Illness Current or untreated psychiatric illness that may significantly influence cognitive testing performance.
- Substance Use or Cognitive-Impacting Medications Current use of substances or medications known to significantly impair cognition or recent substance use that could affect test validity.
- Sensory or Communication Limitations Inadequate English proficiency or speech, hearing, or visual impairments that would prevent valid completion of the digital cognitive assessment.
- Functional or Medical Conditions Affecting Cognition Medical conditions or functional impairments that, in the opinion of the investigator, may interfere with accurate assessment of normal cognitive performance.
- Investigator Discretion Any other condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety, study compliance, or the validity of the normative dataset.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Ages 18-29
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 30-39
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 40-49
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 50-59
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 60-69
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 70-79
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 80-89
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
|
Ages 90-100
|
Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care. Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset. Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Development of normative reference values
Tidsramme: 30 minutes
|
These normative values constitute the primary scientific outcome of the study and will serve as the reference database for interpretation of future individual assessments.
This aligns with the protocol's objective to establish age-, sex-, and education-stratified normative data for the digital cognitive platform.
|
30 minutes
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Intra001
- 1407599 (Annen identifikator: WCG IRB)
- https://www.memoryexam.com/job (Annen identifikator: Intraneuron, LLC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .