Establishing Normal Cognitive Test Scores for Adults Using a Voice-Enabled Digital Testing Platform Across the Lifespan
Purpose
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.
Conditions
- Cognition
- Cognition Disorders
- Cognition - Other
- Dementia
- Alzheimer Disease
- Memory
- Neurocognition
Eligibility
- Eligible Ages
-
Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
-
Yes
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|
Ages 18-29
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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
|
|
-
Diagnostic Test: Voice-based Cognitive Testing
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.
|
Recruiting Locations
The Neurology Center of Southern California
Carlsbad,
California
92011
More Details
- Status
- Recruiting
- Sponsor
- The Neurology Center of Southern California
Study Contact
Gregory Sahagian, MD
760-631-3000
research@intraneuron.com
Notice
Study information shown on this site is derived from
ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.