Cognitive Ability, General Clinical Trial
— INSIGHTOfficial title:
An Integrative System for Enhancing Fluid Intelligence (Gf) Through Human Cognitive Activity, Fitness, High-definition Transcranial Direct-current Brain Stimulation (HD-tDCS), and Nutritional Intervention
Adaptive reasoning and problem-solving are critical skills that allow for accurate decisions to be made based on varying levels of information. In many situations these decisions must be made and communicated under stressful, time-sensitive conditions. In such contexts, an ability to apply inductive and deductive reasoning to complex, ambiguous, and/or novel problems is critical. The objective of the INSIGHT project is to establish a comprehensive and rigorous brain training protocol to significantly improve adaptive reasoning and problem solving. We will examine a variety of interventions (cognitive training, physical fitness training, physiological stimulation, , and combinations thereof) to assess their ability to improve adaptive reasoning and problem solving abilities. Multimodal interventions are hypothesized to act synergistically to significantly enhance fluid intelligence (Gf) and underlying brain structure and function.
Status | Completed |
Enrollment | 521 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - English fluency - US citizen, US permanent resident, or student/work visa sponsored by UIUC - Available for 18-20 weeks - Ages 18 - 44 - Normal or corrected-to-normal vision - Normal or corrected-to-normal hearing Exclusion Criteria: - Previous participant in studies with similar protocols - Currently taking any medication affecting CNS - Has taken medication affecting CNS in past 2 months - Current or planned pregnancy - Recurrent migraines - Concussion in past 2 years - History of stroke - History of epilepsy/seizures - Any medical condition affecting CNS (e.g., history of thyroid cancer) - Any medical condition affecting capability to exercise (e.g., paralysis) - Reading disability/dyslexia - Prior brain surgery - Known brain malformation - Colorblindness - Heart condition that requires physician approval for physical activity - Chest pain (with OR without physical activity) - Loss of balance/dizziness/loss of consciousness - Bone or joint problem that could be made worse by a change in physical activity - Medication for blood pressure or a heart condition |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | Aptima, Inc., Autonomous University of Madrid, Spain, Circinnus LLC, Georgia Institute of Technology, The City College of New York |
United States,
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* Note: There are 68 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bochum Matrices Test | BOMAT is a non-verbal, one-dimensional neuropsychological test of Gf. The test consists of a series of 5x3 matrices of patternswith each matrix missing one field. The participant selects one of six possible answers that complete the matrix. The problems range from simple to complex and are all in black-and-white. Participants complete a 15-min practice and have 45 min to complete as many problems as they can (29 total). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Letter Sets | This test is a measure of Gf. For each problem of the Letter Sets task, the participant is shown 5 sets of letters, with 4 letters in each set. Four of the sets of letters follow a rule, while the fifth set of letters is different from the rest. With the exception of sounds of the sets of letters, shapes of the letters, or potential word formation of the letters, the participant must determine which rule applies to 4 of the letter sets and indicate the 1 letter set that doesn't fit. Participants have 7 minutes to complete as many problems as they can (15 total), with each problem getting progressively more difficult. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Number Series | This test is a measure of Gf. Participants are shown a series of arithmetic number series and need to select the next number in the series from 5 possible answers at the bottom of the screen. The participant is given 5 practice problems at the beginning of instruction, and must complete as many problems as possible in 5 min (10 total). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Rotation Span | This is a test of working memory. Participants must remember a series of arrows presented (16 possible arrows varying in length and direction), while maintaining accuracy on an interleaved letter rotation task (determining if a letter is facing the correct direction after rotation). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Symmetry Span | This is a test of working memory. Participants must remember a series of blocks presented (from a 4x4 grid) while maintaining accuracy on an interleaved symmetry judgment task. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Reading Span | This is a test of working memory. Participants must remember a series of words presented (18 possible 4-letter words) while maintaining accuracy on an interleaved task where they judge sensible or nonsensical sentences. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Garavan | The Garavan task is a serial attention task that measures executive function, specifically task-switching ability. Participants are presented with a series of large and small squares, 10 series/trial in total. Subjects must keep a mental count of how many large and small squares have been presented. For each square, the participant rapidly updates this mental count and then presses the spacebar to see the next square. At the end of the sequence (length is random), a response screen appears and participants report their final count of large and small squares. On a given trial, 11-15 updates are made. Dependent measures are response time for consecutive trials of the same type (no-switch RT) and response time for consecutive trials that differ (switch RT). A cost RT metric can be computed by taking the difference between Switch and No-Switch RT as a measure of set shifting. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Stroop | The Stroop task is a measure of executive function, specifically inhibition. In this task, subjects are asked to indicate the color of each word stimulus. The stimulus may be congruent (the word meaning and text color match), or incongruent (the word meaning and text color differ). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Keep Track | The Keep Track task measures executive function, specifically updating items held in short-term memory. In the task, a series of word stimuli are presented, each belonging to a category. Subjects must remember only the last item presented from each category. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Immediate and Delayed Free Recall - Words | This is a relational memory task. Participants are shown a sequence of 12 words (all 4-letter nouns/verbs), 750 ms for each word. Afterwards, the participant has 30 sec to enter as many words as they can remember from the trial. They do 1 practice trial, followed by 5 test trials. Approximately 20-30 min later, participants are given 90 sec to recall as many words as they can from all 5 previous trials. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Immediate and Delayed Free Recall - Pictures | This is a relational memory task. Participants are shown a sequence of 12 images (all objects, no "action" images), 750 ms for each image. Afterwards, the participant has 30 sec to enter words to describe as many images as they recall from the trial (1 word/image). Each image has multiple words that could be accepted as a correct response (i.e., if shown an image of a chimpanzee, answers "chimpanzee" and "monkey" would both be acceptable). They do 1 practice trial of this task, followed by 5 test trials. Approximately 20-30 minutes later, the participant is given 90 sec to recall as many images as they can from all the previous trials. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Paired Associates | This is a relational memory task. In Paired Associates, a list of 6 unrelated word pairs are presented. At recall, only the first word from each pair is presented. Subjects must enter the second word in the pair. This procedure is repeated with a second list of 6 word pairs. Approximately 20-30 minutes later, the first words from all 12 word pairs are presented. Subjects must enter the second words from each pair. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in VO2 Max (relative, percentile) | Aerobic fitness, defined as maximal oxygen consumption (VO2 max), is assessed using an indirect computerized calorimetry system during a modified Balke treadmill test. During the test, participants' heart rates are monitored using a Polar heart rate monitor, and ratings of perceived exertion are assessed every 2 min. During the test, speed remains constant while incline increases 2-3% every 2 min. Average O2 consumption and respiratory exchange ratio are sampled every 15 sec using a mouthpiece. Relative VO2 max is reported relative to body weight, calculated as ml O2/kg/min. Maximum effort is defined using at least 2 of the following: (1) age-defined maximum heart rate norms (HR > 85% of predicted max HR), (2) respiratory exchange ratio (CO2/O2) >1.1, (3) subjective rate of perceived exertion >17 (of 20), and (4) leveling of VO2 despite increasing aerobic demand. VO2 max percentile is also be reported based on age norms. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Body Mass Index | BMI is calculated from measures of height and weight | 2 administrations: within 2 weeks before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in brain structure | High-resolution structural MRI scan of brain anatomy using MPRAGE sequence, acquired in sagittal orientation (resolution: 0.9 mm, 192 slices, TR 1900 ms, TE 2.32 ms). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in BOLD signal at rest | Using functional MRI to measure blood-oxygen-level-dependent signal while the subject is at rest and not performing a task | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in BOLD signal during task | Functional MRI that measures brain activity (based on hemodynamic response and blood-oxygenation-level dependent signal) during an experimental task. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Object Location Task performance | Completed during fMRI scanning. In the task, an image with 4 objects is presented on a grid of 9 possible locations. Participants are instructed to memorize the spatial locations of all 4 objects and mentally rotate the grid 90°. Participants are then presented with a probe image containing the same 4 objects rotated 90°. Participants must indicate whether or not any of the objects changed location in the rotated probe image. There are three possible responses: either all objects match; 1 object moves to a new location; or 2 objects swap locations. This task is a measure of relational memory. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in 3-back Task performance | Completed during fMRI scanning. Participants are presented with a continuous stream of stimuli (either faces or words), and for every stimulus, the participant must indicate (yes/no) whether or not the current stimulus is the same as the one presented three trials back. This task is a measure of working memory. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Diffusion of Water in the brain | Diffusion tensor imaging (DTI) is a magnetic resonance imaging method that is sensitive to the diffusion of water molecules. Diffusion of water in the brain depends on the tissue type, structural architecture, and presence/absence of barriers within imaging voxels. Using this raw imaging information, diffusion-based properties can be estimated including: 1. fractional anisotropy (FA), which is a measure of whether or not the 3-dimensional diffusion is largely directional (e.g., within an axon; thus, anisotropic diffusion), or if the diffusion is equal in all directions (e.g., within CSF; thus isotropic diffusion); 2. radial diffusivity (RD), which is a measure of how diffusion in the plane transverse to the principal direction of diffusion (i.e., within a cross-section of an axon, rather than down the length of an axon). | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in single-voxel magnetic resonance spectroscopy (MRS) | Technique to measure cell metabolites within a single super voxel of the brain (20 mm3), such as N-acetyl aspartate (NAA) | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Cerebral Blood Flow | During magnetic resonance imaging scans, using the arterial spin labeling technique to acquire multi-slice cerebral blood flow maps | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Saliva-based Genetic Biomarkers | Saliva collected from passive drooling, to be analyzed for biomarkers related to fluid intelligence | One administration, within a week after finishing the 16-week intervention | No |
Secondary | Height | Height measured to calculate BMI estimate | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Weight | Weight measured to calculate BMI estimate | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Demographics Questionnaire | Questionnaire that requests age, birth date, sex, race/ethnicity, occupation. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Big Five Inventory (BFI) Questionnaire | Personality assessment with five dimensions: openness, conscientiousness, extraversion, agreeableness, and neuroticism | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Grit Scale Questionniare | This questionnaire assesses the personality trait of grit, a characteristic associated with passion and adherence to long-term goals, along with strong motivation to achieve goals despite potential obstacles. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | The PSQI assesses sleep habits on eight dimensions over the past month with 11 open-ended and multiple choice questions. Relevant dimensions include sleep duration, disturbance, latency, day dysfunction, efficiency, quality, use of medications to sleep, and an overall binary score of sleep habits. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Godin-Shepard Leisure Time Physical Activity Questionnaire | This survey asks about level of physical activity during leisure time in the past month, from which longer-term exercise habits can be extrapolated. By collecting height, weight, and resting heart rate with this measure, a VO2 max estimation can be reliably calculated. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in UCLA Loneliness Scale | This survey asks about the frequency (never, rarely, sometimes, often) of 20 statements regarding feelings of loneliness and social connection. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Need for Cognition | This survey asks 45 Likert-type questions regarding the value an individual places upon cognition in daily life. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Change in Implicit Theories of Intelligence Survey (ITIS) | The ITIS asks 8 Likert-type questions regarding personal beliefs about the relative fixedness/malleability of intelligence. | 2 administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Physical Activity Enjoyment Scale | The Physical Activity Enjoyment Scale (PACES) measures individuals' enjoyment with their current activity level. | Administered once, within a week after finishing the 16-week intervention period | No |
Secondary | Post-Experiment Survey | This survey was customized for each arm to assess: participant feedback on the various interventions they experienced; strategies developed and used in cognitive training and active control training; expectancy effects of video game-training, physical fitness training, and mindfulness meditation training; and the contribution of external (outside-study) physical activity/exercise and video game play. | Administered once, within 2 weeks after finishing the 16-week intervention period | No |
Secondary | Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) | The Preference and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) measures individuals' preferences for physical activity type and duration. For instance, does one prefer high-intensity activity for a brief period of time, or low-intensity activity for a longer duration? How does one respond to physical challenge and exhaustion? | Two administrations: within a week before beginning and after finishing the 16-week intervention period | No |
Secondary | Game Feedback - Mind Frontiers | Game feedback surveys were developed in-house and administered to evaluate participant responses to cognitive training. These surveys were administered at Sessions 1, 24, and 48 for the 48-session intervention, or at Sessions 1 and 20 for the 20-session intervention. These surveys evaluated enjoyment, engagement, motivation, demand, and frustration with each mini-game. | Administered at Sessions 1, 20 (or 24), and 48 of the Mind Frontiers intervention | No |
Secondary | Game Feedback - Active Control | Game feedback surveys were developed in-house and administered to evaluate participant responses to active control training. These surveys evaluated enjoyment, engagement, motivation, demand, and frustration with each task. | Administered at Sessions 1, 24, and 48 of Active Control intervention | No |
Secondary | Army Physical Readiness Test (APRT) | The APRT is five exercises: (1) 60-yard shuttle run, (2) standing long jump, (3) one-minute of rowers, (4) one-minute of push-ups, and (5) a 1.5 mile run | Administered at Session 1 and Session 28 of the fitness intervention | No |
Secondary | Heart rate | Participants' heart rates were monitored using Polar heart rate monitor E600 during all sessions of the fitness intervention | Data collected continuously during at all 28 fitness intervention sessions | No |
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