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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gregory Sahagian, MD
- Número de teléfono: 760-631-3000
- Correo electrónico: research@intraneuron.com
Ubicaciones de estudio
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California
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Carlsbad, California, Estados Unidos, 92011
- Reclutamiento
- The Neurology Center of Southern California
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Ages 18-29
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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. |
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Ages 30-39
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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. |
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Ages 40-49
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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. |
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Ages 50-59
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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. |
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Ages 60-69
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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. |
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Ages 70-79
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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. |
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Ages 80-89
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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. |
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Ages 90-100
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Development of normative reference values
Periodo de tiempo: 30 minutes
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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.
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30 minutes
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Intra001
- 1407599 (Otro identificador: WCG IRB)
- https://www.memoryexam.com/job (Otro identificador: Intraneuron, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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