Cognitive EnhancementNCT03900702
Training to Enhance Cognition in Older Adults
A study testing Gaze-driven training games in people with Cognitive Enhancement and Aging, run by Jeanne Townsend, PhD at 1 site in United States.
Trial summary
This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Enhancement, Aging
- What is being tested?
- Gaze-driven training games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to Sep 2020
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60-80 years old
- not demented
- living independently; and (4) fluent in English.
Who cannot join
- history of dementia, stroke, head injury involving loss of consciousness
- current psychiatric or neurological disorders other than depression/anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Research on Autism and Development Lab, UCSD
La Jolla, California, 92122
Anne M Engler, 858-246-1931, amengler@ucsd.edu
Sarah Hacker, 8582461931, shacker@ucsd.edu
About this study
Official title: Training Foundational Skills to Enhance Cognition in Older Adults
This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.
Read the detailed description
This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.
- Conditions
- Cognitive Enhancement, Aging
- Being tested
- Gaze-driven training games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze-driven training gamesBehavioural
Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Active comparator | Gaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing. Receives: Behavioral: Gaze-driven training games |
| Wait List Control | No intervention | Wait list then cross over to active intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UFOV Attention Distraction
Subtest from Useful Field of View Task
Measured: 12 weeks
UFOV Speed of Processing
Subtest from Useful Field of View Task
Measured: 12 weeks
Secondary outcomes (1)
Repeatable Battery for Neuropsychological Status (RBANS)
Battery to assess general cognitive function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start15 Feb 2019
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive EnhancementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeanne Townsend, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Jeanne Townsend, PhD, University of California, San Diego
- Investigators
- Jeanne Townsend, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900702
- Sponsor's protocol ID
- U01AG062371
- Other IDs
- U01AG062371
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available by request to the PI 1 year following completion of study. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Foundational Skills to Enhance Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT03900702
- Acronym / sponsor ID
- U01AG062371
- Conditions
- Cognitive Enhancement, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jeanne Townsend, PhDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 3 Apr 2019 (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.
This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.
Detailed description
This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Active comparator | Behavioral: Gaze-driven training gamesGaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing. |
| Wait List Control | No intervention | –Wait list then cross over to active intervention. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60-80 years old
- not demented
- living independently; and (4) fluent in English.
Key exclusion criteria (2 listed)
- history of dementia, stroke, head injury involving loss of consciousness
- current psychiatric or neurological disorders other than depression/anxiety
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 |
|---|---|---|
| Gaze-driven training gamesTraining games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control. | Behavioural | Active Intervention |
Primary outcome
UFOV Attention Distraction
Time frame: 12 weeks
Subtest from Useful Field of View Task
UFOV Speed of Processing
Time frame: 12 weeks
Subtest from Useful Field of View Task
1 secondary outcome
Repeatable Battery for Neuropsychological Status (RBANS)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: Yes. Data will be available by request to the PI 1 year following completion of study. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.
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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.
Jeanne Townsend, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze-driven training games in people with Cognitive Enhancement and Aging, run by Jeanne Townsend, PhD at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne M Engler, BA (8582461931, amengler@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UFOV Attention Distraction (time frame: 12 weeks). The study lists 2 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 3 Apr 2019.