Neurologic ManifestationsNCT00586638
Training Cognitive Control Processes in Older Adults
A study testing Video game based training in people with Neurologic Manifestations and Neurobehavioral Manifestations, run by Columbia University at 1 site in United States.
Trial summary
Control processes are classes of brain activity that initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Manifestations, Neurobehavioral Manifestations
- What is being tested?
- Video game based training
- 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
- Dec 2007to Feb 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-75
- Willingness to adhere to training protocol
- Adequate English proficiency
Who cannot join
- Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance
- Taking medications known to influence cognitive performance
- Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
- Enrolled in a concurrent study that could affect the outcome of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Pilot Study Using a Video Game to Train Cognitive Control Processes in Healthy Older Adults
Control processes are classes of brain activity that initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults.
Read the detailed description
The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into three experimental groups: 1) Video game play with training strategy; 2) Video game play without training strategy (Active Control); 3) Minimal contact (Passive Control). Subjects in Groups 1 and 2 will be instructed to play the complex, high-demand video game, Space Fortress, for 36 one-hour sessions over 12 weeks. Subjects in Group 3 will receive all assessments but will not play the computer game.
- Being tested
- Video game based training
- Keywords
- cognition, cognition disorders, executive function, cognitive control, attentional control, biomedical enhancement, cognitive enhancement, computerized, computer-based, video game
- Medical subject headings
- Neurologic Manifestations, Neurobehavioral Manifestations, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game based trainingBehavioural
36 one-hour sessions over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Video Game play with training strategy Receives: Behavioral: Video game based training |
| 2 | Active comparator | Video game play without training strategy Receives: Behavioral: Video game based training |
| 3 | No intervention | Minimal contact control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological testing
Measured: Week 1, 12, 24
Cognitive-experimental tasks
Measured: Week 1, 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurologic ManifestationsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaakov Stern, Columbia University
- Investigators
- Yaakov Stern, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586638
- Sponsor's protocol ID
- AAAC6151
- Status last verified
- Aug 2015
- First submitted
- 20 Dec 2007
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Blumen HM, Gopher D, Steinerman JR, Stern Y. Training cognitive control in older adults with the space fortress game: the role of training instructions and basic motor ability. Front Aging Neurosci. 2010 Nov 11;2:145. doi: 10.3389/fnagi.2010.00145. eCollection 2010.
PubMed 21120135Stern Y, Blumen HM, Rich LW, Richards A, Herzberg G, Gopher D. Space Fortress game training and executive control in older adults: a pilot intervention. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Nov;18(6):653-77. doi: 10.1080/13825585.2011.613450. Epub 2011 Oct 12.
PubMed 21988726
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using a Video Game to Train Cognitive Control Processes in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT00586638
- Acronym / sponsor ID
- AAAC6151
- Keywords
- cognition, cognition disorders, executive function, cognitive control, attentional control, biomedical enhancement, cognitive enhancement, computerized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Jan 2008 (estimated)
- 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.
Control processes are classes of brain activity that initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults.
Detailed description
The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into three experimental groups: 1) Video game play with training strategy; 2) Video game play without training strategy (Active Control); 3) Minimal contact (Passive Control). Subjects in Groups 1 and 2 will be instructed to play the complex, high-demand video game, Space Fortress, for 36 one-hour sessions over 12 weeks. Subjects in Group 3 will receive all assessments but will not play the computer game.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Video game based trainingVideo Game play with training strategy |
| 2 | Active comparator | Behavioral: Video game based trainingVideo game play without training strategy |
| 3 | No intervention | –Minimal contact control |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60-75
- Willingness to adhere to training protocol
- Adequate English proficiency
Key exclusion criteria (4 listed)
- Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance
- Taking medications known to influence cognitive performance
- Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
- Enrolled in a concurrent study that could affect the outcome of this study
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 |
|---|---|---|
| Video game based training36 one-hour sessions over 12 weeks | Behavioural | 1, 2 |
Primary outcome
Neuropsychological testing
Time frame: Week 1, 12, 24
Cognitive-experimental tasks
Time frame: Week 1, 6, 12, 24
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 5 Aug 2015.
- Results publication: PubMed 21120135Blumen HM, Gopher D, Steinerman JR, Stern Y. Training cognitive control in older adults with the space fortress game: the role of training instructions and basic motor ability. Front Aging Neurosci. 2010 Nov 11;2:145. doi: 10.3389/fnagi.2010.00145. eCollection 2010.
- Results publication: PubMed 21988726Stern Y, Blumen HM, Rich LW, Richards A, Herzberg G, Gopher D. Space Fortress game training and executive control in older adults: a pilot intervention. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Nov;18(6):653-77. doi: 10.1080/13825585.2011.613450. Epub 2011 Oct 12.
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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.
Yaakov Stern, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game based training in people with Neurologic Manifestations and Neurobehavioral Manifestations, run by Columbia University 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 4 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 5 Aug 2015. 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?
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?
Neuropsychological testing (time frame: Week 1, 12, 24). 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?
On the ClinicalTrials.gov record for NCT00586638, which also lists 2 linked publications.
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 5 Aug 2015.