CognitionNCT03206775
D2D Normative Data for Remote Assessments
An observational study of Cognition, run by University of Minnesota at 2 sites in United States.
Trial summary
Phase 1: This is a remote observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with reliable internet access and a device that they can use to access the assessments, such as a laptop or iPad. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Cognitive Assessments (Phase 1), Cognitive Battery A (Phase 2) and Cognitive Battery B (Phase 2)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,271 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2017to 25 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Phase 1: Participants in this study will be healthy adults, aged 18-65, who are fluent in English and do not have a history of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, autism spectrum disorder, mental retardation, neurological disorder, or history of major head injury. Participants will not be restricted by their geological location as they can access the study portal remotely with a reliable internet connection. Pregnant women may participate in this study. Phase 2: Participants in this study will be attendants of the Minnesota State Fair, aged 18-80, who learned English before the age of 12 and can use an iPad without assistance. Participants may be pregnant or have a medical, developmental, psychiatric, or neurological condition.
Who may be able to join
None listed.
Who cannot join
- Unable or unwilling to provide informed consent
- Not fluent in written/spoken English
- Unable to use an iPad or computer to complete visual and/or auditory cognitive assessments without assistance
- Presence of a medical or behavioral condition that would prohibit participation in the trial
- Participant has used illicit substances or alcohol within the past 8 hours
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55454
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Collection of Normative Data for iPad-Based Cognitive Assessment Tools
Phase 1: This is a remote observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with reliable internet access and a device that they can use to access the assessments, such as a laptop or iPad. Participants will complete up to 6 Posit Science assessments in different domains of cognition, which should last approximately 30 minutes.
Phase 2: This is an in person observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-80 who are fluent in English. Participants will complete batteries of cognitive assessments developed by Posit Science, which include combinations of visual, auditory, and social cognitive assessments, and self-report questionnaires. This study will be conducted at the Driven to Discover building at the Minnesota State Fair. Participation will last approximately 20 minutes.
Read more
Phase 3: Participants in Phase 3 will complete a Posit Science assessment battery and self-report questionnaires. Each participant will be asked to provide brief demographic and medical history data. Participants will be aged 18-35 and will be students at the University of Minnesota who are enrolled in the Research Experience Points program. Participants will complete the assessment battery remotely; the battery will take approximately 45-60 minutes to complete.
Phase 4: This is a pilot program to test the use of remote cognitive assessment and training in adolescents with an anxiety diagnosis and healthy controls. Participants will complete a short assessment battery, then will receive 4 hours of cognitive training over 2 weeks at home. Then they will repeat the battery. Total participation should last approximately 5 hours over 2-3 weeks and will be completed entirely remotely.
Read the detailed description
Phase 1: Remote Assessment with Old Battery (Enrollment period: June-August 2017. CLOSED TO ENROLLMENT) Participants who have successfully completed the online consent process may begin study procedures. A member of the research staff will connect the participant to the Posit Science battery remotely using their laptop or iPad through the BrainHQ portal. All Posit Science assessments have a brief training section before the assessment begins. Participants will be instructed to be in a quiet place free of distractions where they can turn up the volume on their device or use headphones to complete the auditory portions of the assessment. The battery will consist of 6 exercises and will last approximately 20 minutes, which will be completed in a single sitting. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an external device for data analysis and interpretation. Once participants have completed the batter, a member of the study staff will send their compensation.
Phase 2: Minnesota State Fair (Enrollment period: 2017-2022) Participants who have successfully completed the consent process may begin study procedures. A member of the research staff will connect the participant to the REDCap self-report surveys on an iPad. The surveys will be contained within a directory listed under the participant's unique study identifier and will not contain any personally identifying information. The first survey will collect demographic information such as age, gender, ethnicity/race, zip code of residence, education level, current medications, and personal and familial psychiatric and neurological history. This information will be collected in a self-report survey form to avoid embarrassment or stigma that could result if the participant was overheard answering these questions. After completing the demographic survey and brief medical history, all participants will complete self report questionnaires. The self-report assessments should take approximately 2 minutes to complete.
After the completion of the self-report items, the participant will be automatically redirected to the cognitive battery to which they have been randomized. They will be asked to log in to the BrainHQ portal using the same email address they provided before. They will be prompted for their name; study staff will instruct participants to enter "State" for their first name and "Fair" for their last name. However, study staff will not directly oversee participants while they create their account, and so some may not follow these instructions and may disclose their full name to Posit Science. All Posit Science assessments have a brief training section before the assessment begins. If the participant is still having trouble understanding the assessment, study staff will be available to help explain the tasks. Participants will be provided with over-the-ear headphones with disposable sanitary pads for auditory components. Each battery will consist of 4-6 Posit Science assessments, which last approximately 2-3 minutes each. The cognitive battery should last approximately 12-15 minutes. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an AHC managed device for analysis and interpretation. When downloaded to the AHC server, they will be de-identified and collated using a unique participant ID.
At the end of the cognitive assessment battery, participants will be asked to complete a short feasibility survey on REDCap which will ask them their opinion of the tasks they completed and how likely they would be to use these kinds of programs. This survey should take approximately 1-2 minutes. Then participants will receive their compensation and their participation will be complete.
Phase 3: Research Experience Program (REP) Project (Enrollment period: Spring 2018; future enrollment planned) Adult students at the University of Minnesota who are enrolled in the Research Experience Points (REP) program may enroll in this study to be awarded points for class credit. We will request that participants complete the study in a quiet environment free of distractions with a reliable internet connection, and that they do not participate if they have consumed alcohol or illicit substances in the last 8 hours/are under the influence of illicit substances. We will also recommend the use of over-the-ear headphones for the study. Participants will complete an online consent form independently, though they may contact research staff at any time if they have questions. After completing the consent form, participants will be redirected to the COMPAS self-report measures. After the assessment suite is complete, the participants will be automatically re-directed to the Posit Science website to complete the assessment battery. Total participation should take approximately 45-60 minutes.
Phase 4: Pilot Adolescent Cognitive Training (Enrollment period: Summer 2018. CLOSED TO ENROLLMENT) We will recruit adolescents without a mental health diagnosis and with a diagnosis of anxiety by using the UMP Psychiatry Clinic recruitment registry, contacting previous research participants, by advertising in the community and online (Facebook and Department website). Parents/guardians will be asked to provide a brief demographic and medical history about their child. If the participant is over 18, they may complete this independently, but are instructed that they can work with their parent or guardian if they choose to do so. The adolescent will then complete the assessment battery, 4 hours of BrainHQ training games over 2 weeks, and repeat the assessment battery. Total participation should last approximate 5 hours and will be completed entirely remotely. Participants will receive their compensation via email, using the same account that was used for sending the link to the battery
- Conditions
- Cognition
- Being tested
- Cognitive Assessments (Phase 1), Cognitive Battery A (Phase 2), Cognitive Battery B (Phase 2), Cognitive Battery C (Phase 2)
- Keywords
- cognitive training, Self-report assessments, Normative Data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Assessments (Phase 1)Behavioural
Participants will participate in up to 6 assessments in 4 domains of cognition: Processing Speed; Executive Attention; Learning and Memory; and Social Cognition.
Assessments:
- Visual Sweeps
- Sustained Visual Attention
- Associative Learning--Visual
- Associative Learning--Auditory
- Emotion Motion
- Voice Choice
Cognitive Battery A (Phase 2)Behavioural
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete self-report surveys.
Assessments:
- On trails: Learning
- Line Length Discrimination
- Tap the Emotion
- Sound Sweeps
- BIS/BAS
- TEPS
- Feasibility survey
Cognitive Battery B (Phase 2)Behavioural
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete the complete self-report surveys.
Assessments:
- Visual Time Order Judgment
- Target Tracker
- Emotional Face
- Auditory Sound Discrimination
- BIS/BAS
- TEPS
- Feasiblity assessment
Cognitive Battery C (Phase 2)Behavioural
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant willcomplete self-report surveys.
Assessments:
- Stroop 2AFC
- Visual Task Switcher
- Beep Seeker
- Voice Choice
- BIS/BAS
- TEPS
- Feasibility Survey
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls (Phase 1) | Participants will participate in Cognitive Assessments (Phase 1) developed by Posit Science Receives: Behavioral: Cognitive Assessments (Phase 1) | |
| Healthy Controls, Battery A (Phase 2) | Participants will complete the Cognitive Battery A (Phase 2) developed by Posit Science while at the Minnesota State Fair. Receives: Behavioral: Cognitive Battery A (Phase 2) | |
| Healthy Controls, Battery B (Phase 2) | Participants will complete the Cognitive Battery B (Phase 2) developed by Posit Science while at the Minnesota State Fair. Receives: Behavioral: Cognitive Battery B (Phase 2) | |
| Healthy Controls, Battery C (Phase 2) | Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair. Receives: Behavioral: Cognitive Battery C (Phase 2) | |
| Healthy Controls (Phase 3) | Participants will complete the full Posit Science cognitive assessment battery and self-report questionnaires for credit in the Research Experience Program at the University of Minnesota. | |
| Healthy Controls, Battery D (Phase 2) | Participants will complete the Cognitive Battery E (Phase 2) developed by Posit Science while at the Minnesota State Fair. | |
| Healthy Controls, Battery E (Phase 2) | Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair. | |
| Adolescents with anxiety diagnosis (Phase 4) | Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science. | |
| Adolescents, healthy controls (Phase 4) | Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Sweeps
Phase 1: Participants watch two spatial frequency sweeps and determine whether each one swept inward or outward
Measured: 4 minutes
Sustained Visual Attention
Phase 1: Participants are asked to press the spacebar as fast as they can whenever a star appears at the top of the screen (don't press when it appears at the bottom of the screen)
Measured: 4 minutes
Associative Learning--Visual
Phase 1: Participants will see a ring of items. They are asked to memorize the items and their locations.
Measured: 4 minutes
Associative Learning--Auditory
Phase 1: Participants will hear a sequence of syllables. They are asked to memorize the syllables and repeat the sequence by clicking on the words.
Measured: 4 minutes
Emotion Motion
Phase 1: Participants will see a video of a person showing a facial expression on every trial. They are asked to select the correct emotion
Measured: 4 Minutes
Voice Choice
Phase 1: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence
Measured: 4 Minutes
On Trails: Learning
Phase 2, Battery A: Participants see two circles connected by paths. Remember the path from A to B, and click the circles in the order indicated. If the participant makes a mistake, the path is shown again.
Measured: 4 minutes
Line Length Discrimination
Phase 2, Battery A: Participants watch two lines surrounded by stars and determine which one is longer.
Measured: 4 minutes
Tap the Emotion
Phase 2, Battery A: This is an executive function go/no-go task that captures both inhibitory control and sustained attention abilities. Participants see a series of faces, each presented for a limited time. Participants are instructed to tap the button every time they see a happy or sad face, and to not tap the button when they see a neutral face
Measured: 4 minutes
Sound Sweeps
Phase 2, Battery A: Participants are presented with two subsequent tones that eithe rrise or lower in pitch, and they are asked to identify the direction of the pitch change.
Measured: 4 minutes
Visual Time Order Judgment
Phase 2, Battery B: Watch two visual patterns shown one after the other and determine which one was presented first
Measured: 4 minutes
Target Tracker
Phase 2, Battery B: Keep track of the targets as all the objects (targets and distractors) move around the screen.
Measured: 4 minutes
Emotional Face
Phase 2, Battery B: This is an emotional stroop task that provides a measure of executive attention. In each trial, an expressive face is shown and overlaid with a congruent or incongruent word (stroop effect). Participants see a series of faces, each presented for a limited time. Identify the emotion of the face as quickly as possible. If the face is displaying happiness, tap the HAPPY button. If the face is displaying fear, tap the FEAR button. Increased reaction time to incongruent stimulus combinations capture capacity for conflict resolution.
Measured: 4 minutes
Auditory Sound Discrimination
Phase 2, Battery B: Participants must determine which of two similar sounding syllable phonemes were spoken.
Measured: 4 minutes
Stroop 2AFC
Phase 2, Battery C: The name of a color written in colored text appears in the screen. Participants elect the color of the text by tapping left/right keyboard arrow as quickly as they can.
Measured: 4 minutes
Visual Task Switcher
Phase 2, Battery C: Two shapes are presented rapidly on the screen. Respond quickly if the two shapes share the same criteria, which changes from trial to trial (e.g., color).
Measured: 4 minutes
Beep Seeker
Phase 2, Battery C: Participants are presented with a target beep tone and then asked to identify it in the presence of distracting tones.
Measured: 4 minutes
Voice Choice
Phase 2, Battery C: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence
Measured: 4 minutes
Secondary outcomes (3)
Behavioral Inhibition Scale/Behavioral Activation Scale (BIS/BAS)
Participants will answer self-report questions to determine behavioral inhibition and behavioral activation. The scale is set at 1-4 1 not active at all and 5 being the most active
Measured: 4 minutes
Temporal Experience of Pleasure Scale (TEPS)
Participants will answer self-report questions to determine their anticipatory and consummatory pleasure. Scale range is 1-6 1 being least pleasurable and 6 being the most pleasurable
Measured: 4 minutes
Feasibility ratings
Participants will answer self report questions about the accessibility of the Posit Science cognitive assessments.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start6 Jun 2017
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Posit Science Corporation
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206775
- Sponsor's protocol ID
- STUDY00000319
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Normative Data for iPad-Based Cognitive Assessment Tools
- ClinicalTrials.gov ID
- NCT03206775
- Acronym / sponsor ID
- STUDY00000319
- Conditions
- Cognition
- Keywords
- cognitive training, Self-report assessments, Normative Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,271 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Posit Science Corporation
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1: This is a remote observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with reliable internet access and a device that they can use to access the assessments, such as a laptop or iPad. Participants will complete up to 6 Posit Science assessments in different domains of cognition, which should last approximately 30 minutes.
Phase 2: This is an in person observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-80 who are fluent in English. Participants will complete batteries of cognitive assessments developed by Posit Science, which include combinations of visual, auditory, and social cognitive assessments, and self-report questionnaires. This study will be conducted at the Driven to Discover building at the Minnesota State Fair. Participation will last approximately 20 minutes.
Phase 3: Participants in Phase 3 will complete a Posit Science assessment battery and self-report questionnaires. Each participant will be asked to provide brief demographic and medical history data. Participants will be aged 18-35 and will be students at the University of Minnesota who are enrolled in the Research Experience Points program. Participants will complete the assessment battery remotely; the battery will take approximately 45-60 minutes to complete.
Phase 4: This is a pilot program to test the use of remote cognitive assessment and training in adolescents with an anxiety diagnosis and healthy controls. Participants will complete a short assessment battery, then will receive 4 hours of cognitive training over 2 weeks at home. Then they will repeat the battery. Total participation should last approximately 5 hours over 2-3 weeks and will be completed entirely remotely.
Detailed description
Phase 1: Remote Assessment with Old Battery (Enrollment period: June-August 2017. CLOSED TO ENROLLMENT) Participants who have successfully completed the online consent process may begin study procedures. A member of the research staff will connect the participant to the Posit Science battery remotely using their laptop or iPad through the BrainHQ portal. All Posit Science assessments have a brief training section before the assessment begins. Participants will be instructed to be in a quiet place free of distractions where they can turn up the volume on their device or use headphones to complete the auditory portions of the assessment. The battery will consist of 6 exercises and will last approximately 20 minutes, which will be completed in a single sitting. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an external device for data analysis and interpretation. Once participants have completed the batter, a member of the study staff will send their compensation.
Phase 2: Minnesota State Fair (Enrollment period: 2017-2022) Participants who have successfully completed the consent process may begin study procedures. A member of the research staff will connect the participant to the REDCap self-report surveys on an iPad. The surveys will be contained within a directory listed under the participant's unique study identifier and will not contain any personally identifying information. The first survey will collect demographic information such as age, gender, ethnicity/race, zip code of residence, education level, current medications, and personal and familial psychiatric and neurological history. This information will be collected in a self-report survey form to avoid embarrassment or stigma that could result if the participant was overheard answering these questions. After completing the demographic survey and brief medical history, all participants will complete self report questionnaires. The self-report assessments should take approximately 2 minutes to complete.
After the completion of the self-report items, the participant will be automatically redirected to the cognitive battery to which they have been randomized. They will be asked to log in to the BrainHQ portal using the same email address they provided before. They will be prompted for their name; study staff will instruct participants to enter "State" for their first name and "Fair" for their last name. However, study staff will not directly oversee participants while they create their account, and so some may not follow these instructions and may disclose their full name to Posit Science. All Posit Science assessments have a brief training section before the assessment begins. If the participant is still having trouble understanding the assessment, study staff will be available to help explain the tasks. Participants will be provided with over-the-ear headphones with disposable sanitary pads for auditory components. Each battery will consist of 4-6 Posit Science assessments, which last approximately 2-3 minutes each. The cognitive battery should last approximately 12-15 minutes. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an AHC managed device for analysis and interpretation. When downloaded to the AHC server, they will be de-identified and collated using a unique participant ID.
At the end of the cognitive assessment battery, participants will be asked to complete a short feasibility survey on REDCap which will ask them their opinion of the tasks they completed and how likely they would be to use these kinds of programs. This survey should take approximately 1-2 minutes. Then participants will receive their compensation and their participation will be complete.
Phase 3: Research Experience Program (REP) Project (Enrollment period: Spring 2018; future enrollment planned) Adult students at the University of Minnesota who are enrolled in the Research Experience Points (REP) program may enroll in this study to be awarded points for class credit. We will request that participants complete the study in a quiet environment free of distractions with a reliable internet connection, and that they do not participate if they have consumed alcohol or illicit substances in the last 8 hours/are under the influence of illicit substances. We will also recommend the use of over-the-ear headphones for the study. Participants will complete an online consent form independently, though they may contact research staff at any time if they have questions. After completing the consent form, participants will be redirected to the COMPAS self-report measures. After the assessment suite is complete, the participants will be automatically re-directed to the Posit Science website to complete the assessment battery. Total participation should take approximately 45-60 minutes.
Phase 4: Pilot Adolescent Cognitive Training (Enrollment period: Summer 2018. CLOSED TO ENROLLMENT) We will recruit adolescents without a mental health diagnosis and with a diagnosis of anxiety by using the UMP Psychiatry Clinic recruitment registry, contacting previous research participants, by advertising in the community and online (Facebook and Department website). Parents/guardians will be asked to provide a brief demographic and medical history about their child. If the participant is over 18, they may complete this independently, but are instructed that they can work with their parent or guardian if they choose to do so. The adolescent will then complete the assessment battery, 4 hours of BrainHQ training games over 2 weeks, and repeat the assessment battery. Total participation should last approximate 5 hours and will be completed entirely remotely. Participants will receive their compensation via email, using the same account that was used for sending the link to the battery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Healthy controls (Phase 1) | – | Behavioral: Cognitive Assessments (Phase 1)Participants will participate in Cognitive Assessments (Phase 1) developed by Posit Science |
| Healthy Controls, Battery A (Phase 2) | – | Behavioral: Cognitive Battery A (Phase 2)Participants will complete the Cognitive Battery A (Phase 2) developed by Posit Science while at the Minnesota State Fair. |
| Healthy Controls, Battery B (Phase 2) | – | Behavioral: Cognitive Battery B (Phase 2)Participants will complete the Cognitive Battery B (Phase 2) developed by Posit Science while at the Minnesota State Fair. |
| Healthy Controls, Battery C (Phase 2) | – | Behavioral: Cognitive Battery C (Phase 2)Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair. |
| Healthy Controls (Phase 3) | – | –Participants will complete the full Posit Science cognitive assessment battery and self-report questionnaires for credit in the Research Experience Program at the University of Minnesota. |
| Healthy Controls, Battery D (Phase 2) | – | –Participants will complete the Cognitive Battery E (Phase 2) developed by Posit Science while at the Minnesota State Fair. |
| Healthy Controls, Battery E (Phase 2) | – | –Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair. |
| Adolescents with anxiety diagnosis (Phase 4) | – | –Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science. |
| Adolescents, healthy controls (Phase 4) | – | –Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Phase 1: Participants in this study will be healthy adults, aged 18-65, who are fluent in English and do not have a history of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, autism spectrum disorder, mental retardation, neurological disorder, or history of major head injury. Participants will not be restricted by their geological location as they can access the study portal remotely with a reliable internet connection. Pregnant women may participate in this study. Phase 2: Participants in this study will be attendants of the Minnesota State Fair, aged 18-80, who learned English before the age of 12 and can use an iPad without assistance. Participants may be pregnant or have a medical, developmental, psychiatric, or neurological condition.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Unable or unwilling to provide informed consent
- Not fluent in written/spoken English
- Unable to use an iPad or computer to complete visual and/or auditory cognitive assessments without assistance
- Presence of a medical or behavioral condition that would prohibit participation in the trial
- Participant has used illicit substances or alcohol within the past 8 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Assessments (Phase 1)Participants will participate in up to 6 assessments in 4 domains of cognition: Processing Speed; Executive Attention; Learning and Memory; and Social Cognition. Assessments: * Visual Sweeps * Sustained Visual Attention * Associative Learning--Visual * Associative Learning--Auditory * Emotion Motion * Voice Choice | Behavioural | Healthy controls (Phase 1) |
| Cognitive Battery A (Phase 2)Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete self-report surveys. Assessments: * On trails: Learning * Line Length Discrimination * Tap the Emotion * Sound Sweeps * BIS/BAS * TEPS * Feasibility survey | Behavioural | Healthy Controls, Battery A (Phase 2) |
| Cognitive Battery B (Phase 2)Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete the complete self-report surveys. Assessments: * Visual Time Order Judgment * Target Tracker * Emotional Face * Auditory Sound Discrimination * BIS/BAS * TEPS * Feasiblity assessment | Behavioural | Healthy Controls, Battery B (Phase 2) |
| Cognitive Battery C (Phase 2)Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant willcomplete self-report surveys. Assessments: * Stroop 2AFC * Visual Task Switcher * Beep Seeker * Voice Choice * BIS/BAS * TEPS * Feasibility Survey | Behavioural | Healthy Controls, Battery C (Phase 2) |
Primary outcome
Visual Sweeps
Time frame: 4 minutes
Phase 1: Participants watch two spatial frequency sweeps and determine whether each one swept inward or outward
Sustained Visual Attention
Time frame: 4 minutes
Phase 1: Participants are asked to press the spacebar as fast as they can whenever a star appears at the top of the screen (don't press when it appears at the bottom of the screen)
Associative Learning--Visual
Time frame: 4 minutes
Phase 1: Participants will see a ring of items. They are asked to memorize the items and their locations.
Associative Learning--Auditory
Time frame: 4 minutes
Phase 1: Participants will hear a sequence of syllables. They are asked to memorize the syllables and repeat the sequence by clicking on the words.
Emotion Motion
Time frame: 4 Minutes
Phase 1: Participants will see a video of a person showing a facial expression on every trial. They are asked to select the correct emotion
Voice Choice
Time frame: 4 Minutes
Phase 1: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence
On Trails: Learning
Time frame: 4 minutes
Phase 2, Battery A: Participants see two circles connected by paths. Remember the path from A to B, and click the circles in the order indicated. If the participant makes a mistake, the path is shown again.
Line Length Discrimination
Time frame: 4 minutes
Phase 2, Battery A: Participants watch two lines surrounded by stars and determine which one is longer.
Tap the Emotion
Time frame: 4 minutes
Phase 2, Battery A: This is an executive function go/no-go task that captures both inhibitory control and sustained attention abilities. Participants see a series of faces, each presented for a limited time. Participants are instructed to tap the button every time they see a happy or sad face, and to not tap the button when they see a neutral face
Sound Sweeps
Time frame: 4 minutes
Phase 2, Battery A: Participants are presented with two subsequent tones that eithe rrise or lower in pitch, and they are asked to identify the direction of the pitch change.
Visual Time Order Judgment
Time frame: 4 minutes
Phase 2, Battery B: Watch two visual patterns shown one after the other and determine which one was presented first
Target Tracker
Time frame: 4 minutes
Phase 2, Battery B: Keep track of the targets as all the objects (targets and distractors) move around the screen.
Emotional Face
Time frame: 4 minutes
Phase 2, Battery B: This is an emotional stroop task that provides a measure of executive attention. In each trial, an expressive face is shown and overlaid with a congruent or incongruent word (stroop effect). Participants see a series of faces, each presented for a limited time. Identify the emotion of the face as quickly as possible. If the face is displaying happiness, tap the HAPPY button. If the face is displaying fear, tap the FEAR button. Increased reaction time to incongruent stimulus combinations capture capacity for conflict resolution.
Auditory Sound Discrimination
Time frame: 4 minutes
Phase 2, Battery B: Participants must determine which of two similar sounding syllable phonemes were spoken.
Stroop 2AFC
Time frame: 4 minutes
Phase 2, Battery C: The name of a color written in colored text appears in the screen. Participants elect the color of the text by tapping left/right keyboard arrow as quickly as they can.
Visual Task Switcher
Time frame: 4 minutes
Phase 2, Battery C: Two shapes are presented rapidly on the screen. Respond quickly if the two shapes share the same criteria, which changes from trial to trial (e.g., color).
Beep Seeker
Time frame: 4 minutes
Phase 2, Battery C: Participants are presented with a target beep tone and then asked to identify it in the presence of distracting tones.
Voice Choice
Time frame: 4 minutes
Phase 2, Battery C: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence
3 secondary outcomes
Behavioral Inhibition Scale/Behavioral Activation Scale (BIS/BAS)
Time frame: 4 minutes
Temporal Experience of Pleasure Scale (TEPS)
Time frame: 4 minutes
Feasibility ratings
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Cognition
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Vinogradov, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Sweeps (time frame: 4 minutes). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.