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The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups to mechanistically tease apart the possible presence of any synergistic effects on cognitive abilities through the combination of cognitive & physical challenges.
Cognitive control functions (e.g. attention, working memory, goal-management) dictate our ability to learn and accomplish selected behavioral goals, with deficiencies in these processes found in a range of mental illnesses. The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups: 1) BBT, 2) "Brain Training" (BBT played with a gamepad controller), 3) "Body Training" (BBT without any cognitive demands), and 4) an expectancy matched placebo control group. Individuals will engage in eight weeks of training within our Neuroscape Laboratory, with pre- and post-training assessments evaluating physical, cognitive, and neural measures. The completion of this project will result in a more sophisticated understanding of how the integration of cognitive and physical training potentially impacts cognitive control processes, setting the stage for more effective interventions for mental illness and learning-related impairments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBT | Experimental | Body-Brain Trainer |
|
| Body Trainer | Active Comparator | Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol. |
|
| Brain Trainer | Active Comparator | The "Brain Trainer" group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). |
|
| Expectancy Matched Control Group | Placebo Comparator | The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body-Brain Trainer | Behavioral | A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| mCPT (Derived From Test of Variables of Attention (T.O.V.A.)) | A change from baseline regarding measurement of sustained attention and impulsivity abilities | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline | A change from baseline regarding measurement of working memory abilities in the presence of interference. This task involved memorizing a face for set amount of time, followed by a delay period (during which participants were exposed to different types of distracting images), followed by the presentation of an image that participants are cued to respond whether or not this image matches the initial one presented. Here we examined a version of response time variance derived from exGaussain Statistics called tau, that is a measure of response time variance that considers the tails on a Gaussian distribution with respect to response time variability. This analysis allows one to see how variant one's performance could be on trials that fall outside of their mean performance distribution. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Measures | Assessing a change in systolic & diastolic pressure following the intervention | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
| Limit of Stability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin A. Anguera, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Neuroscape | San Francisco | California | 94158 | United States |
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We were only able to enroll in 2 of the 4 arms for this study due to resource limitations for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Body-Brain Trainer | Body-Brain Trainer Body-Brain Trainer: A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
| FG001 | Expectancy Matched Control Group | The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition Expectancy Matched Control: The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Body-Brain Trainer | Body-Brain Trainer Body-Brain Trainer: A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | mCPT (Derived From Test of Variables of Attention (T.O.V.A.)) | A change from baseline regarding measurement of sustained attention and impulsivity abilities | Due to logistical/practical consideration surrounding funding for this project, we were forced to only collect data for 2 gropus | Posted | Mean | Standard Deviation | milliseconds | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
Each participant was in the primary data collection period of the study for approximately 10 weeks (1 week for the collection of baseline measures, 8 weeks for training, and another week for the collection of post-training measures. There was a follow-up data collection 1 year following their post-training data collection to test for long-term beneficial effects. Thus the period of time over which we assessed for adverse events was 14.5 months in total.
No difference in the definition of an adverse event from that listed at clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BBT - Body-Brain Trainer | Body-Brain Trainer Body-Brain Trainer: A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
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We were not able to collect all four arms as originally intended due to logistical and resource issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joaquin A. Anguera, Associate Professor, Neuroscape | UCSF | University of California San Francisco | 415-502-7322 | joaquin.anguera@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2022 | Apr 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2023 | Apr 17, 2025 | SAP_001.pdf |
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|
| Body Trainer | Behavioral | A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The "Body Trainer" group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During "Body Training", participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present |
|
| Brain Trainer | Behavioral | The "Brain Trainer" group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
|
| Expectancy Matched Control | Behavioral | The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group. |
|
| At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
Assessing a change in balance following the intervention |
| At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
| EEG Functional Measure (Event-related Spectral Perturbation) | Assessing a change in event-related spectral perturbation following the intervention | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
| EEG Functional Measure (Long-range Coherence as Measured Via Phase Locking Values): Decibels Prior to and at 9 Weeks Post Baseline | Assessing a change in coherence following the intervention. This measure assesses the synchronization of neural activity between frontal and posterior regions of the brain, looking to quantify how coherent these signals are. For example, if the activity at the front of the head shows greater synchrony with activity at the back of the head, than this measure of interest would show a greater amount of coherence. Coherence of this type is reported in the form of phase locking value, which tells us how consistently the timing of those rhythms stay aligned across many repetitions of the same event. PLV close to 1 (or 100%) → very consistent timing, almost perfectly locked together, whereas PLV close to 0 → timing is random, no consistent relationship. PLVs are typically reported in decibels to facilitate seeing subtle changes, compare across conditions, and stay consistent with other brainwave measures. | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
| BG001 | Expectancy Matched Control Group | The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition Expectancy Matched Control: The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mCPT | Mean | Standard Deviation | milliseconds |
|
| EEG | Mean | Standard Deviation | decibles |
|
| OG001 | Body Trainer | Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol. Body Trainer: A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The "Body Trainer" group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During "Body Training", participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present |
| OG002 | Brain Trainer | The "Brain Trainer" group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). Brain Trainer: The "Brain Trainer" group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks. |
| OG003 | Expectancy Matched Control Group | The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition Expectancy Matched Control: The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group. |
|
|
| Secondary | Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline | A change from baseline regarding measurement of working memory abilities in the presence of interference. This task involved memorizing a face for set amount of time, followed by a delay period (during which participants were exposed to different types of distracting images), followed by the presentation of an image that participants are cued to respond whether or not this image matches the initial one presented. Here we examined a version of response time variance derived from exGaussain Statistics called tau, that is a measure of response time variance that considers the tails on a Gaussian distribution with respect to response time variability. This analysis allows one to see how variant one's performance could be on trials that fall outside of their mean performance distribution. | Posted | Mean | Standard Deviation | msec | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
|
|
| Other Pre-specified | Blood Pressure Measures | Assessing a change in systolic & diastolic pressure following the intervention | Posted | Mean | Standard Deviation | mmHG | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
|
|
| Other Pre-specified | Limit of Stability | Assessing a change in balance following the intervention | Posted | Mean | Standard Deviation | meters/sec | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
|
|
| Other Pre-specified | EEG Functional Measure (Event-related Spectral Perturbation) | Assessing a change in event-related spectral perturbation following the intervention | Posted | Mean | Standard Deviation | dB (decibles) | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
|
|
| Other Pre-specified | EEG Functional Measure (Long-range Coherence as Measured Via Phase Locking Values): Decibels Prior to and at 9 Weeks Post Baseline | Assessing a change in coherence following the intervention. This measure assesses the synchronization of neural activity between frontal and posterior regions of the brain, looking to quantify how coherent these signals are. For example, if the activity at the front of the head shows greater synchrony with activity at the back of the head, than this measure of interest would show a greater amount of coherence. Coherence of this type is reported in the form of phase locking value, which tells us how consistently the timing of those rhythms stay aligned across many repetitions of the same event. PLV close to 1 (or 100%) → very consistent timing, almost perfectly locked together, whereas PLV close to 0 → timing is random, no consistent relationship. PLVs are typically reported in decibels to facilitate seeing subtle changes, compare across conditions, and stay consistent with other brainwave measures. | Posted | Mean | Standard Deviation | Decibels | At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected) |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Body Trainer | Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol. Body Trainer: A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The "Body Trainer" group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During "Body Training", participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Brain Trainer | The "Brain Trainer" group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). Brain Trainer: The "Brain Trainer" group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Expectancy Matched Control Group | The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition Expectancy Matched Control: The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group. | 0 | 25 | 0 | 25 | 0 | 25 |
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