Clinical trial NCT02780739: INSIGHT, A Comprehensive, Multidisciplinary Brain Training System
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Keywords: Psychological Tests
Neuropsychological Tests
Transcranial Direct Current Stimulation
Exercise
Circuit-Based Exercise
Video Games
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Cognition
Executive Function
Learning
Problem Solving
Transfer (Psychology)
Decision Making
Brain
Gray Matter
White Matter
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: The City College of New York
name: Aptima, Inc.
name: Georgia Institute of Technology
name: Circinnus LLC
name: Autonomous University of Madrid, Spain
First posted: 2016-05-23
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: Recent innovations in cognitive neuroscience have advanced understanding of the neurobiological foundations of fluid intelligence (Gf) and adaptive reasoning and problem solving (ARP). Rather than engaging a single brain structure (e.g., prefrontal cortex) or operating at a fixed level of performance throughout adulthood, emerging neuroscience evidence indicates that Gf and ARP are mediated by a distributed neural system whose functions can be significantly enhanced by specific types of interventions, including cognitive training, high-definition transcranial direct-current brain stimulation (HD-tDCS), and physical fitness training. The main objective of the INSIGHT project is to establish and validate a comprehensive and rigorous brain training protocol that incorporates the best available interventions for the enhancement of Gf and ARP.

The project was divided into two phases, with the first occurring in February -November 2014 and the second occurring February - December 2015. The two phases were similar in structure and goals/hypotheses, but had several methodological differences in terms of interventions, arms, and outcome measures. This document contains information pertinent to only the 2014 phase, which examined the relative contributions of physical fitness intervention, video-game based training, and high-definition transcranial direct-current brain stimulation (HD-tDCS) to the improvement of Gf/ARP, executive function, working memory, relational memory, physical fitness level, and brain structure/function.

Arms/groups completed 1 week of testing to establish baseline measurements of cognitive abilities, physical fitness, and brain structure/function. 16 weeks of various intervention protocols. These protocols could include single or multiple intervention type(s) with varying schedules. Three 70-min training sessions were completed per week, so all arms completed 56 hours of training, total. Following completion of the intervention period was 1 week of post-assessment to measure changes in cognitive abilities, physical fitness, and brain structure/function.

Technical Justification for Physical Fitness Intervention: The beneficial effects of physical fitness on cognitive performance and brain health have been documented in many studies. For example, this literature suggests that increased exercise leads to the birth of new neurons in the hippocampus (a key brain region underlying Gf), increased connections among neurons throughout the brain, the development of new vasculature structure, increased production of neurotrophic proteins, enhanced learning and memory, and enhanced executive control including attention and inhibition, working memory, mental flexibility, and action monitoring. In particular, (1) exercise effects are largest for tasks that involve executive control functions for working memory, planning, and problem solving - abilities that are essential for Gf and ARP; and (2) aerobic exercise training, when combined with strength and flexibility training, had a greater positive effect on cognition compared to exercise training programs that included only aerobic components. Such findings provide important justification for the physical activity intervention proposed here. Hence, the proposed fitness intervention employs a combined aerobic/resistance training program to further enhance the benefits of cognitive training on Gf and ARP.

Technical Justification for Video Game-Based Training: Training on five cognitive skills - (1) processing speed, (2) attention, (3) working memory, (4) relational memory, and (5) cognitive flexibility - has been shown to provide promising transfer results to Gf and other relevant constructs. This training regime is the basis for the design of the Mind Frontiers software platform. Mind Frontiers includes an integrated suite of mini-games that are designed to train these five core cognitive skills. The mechanics, as abstractions of the cognitive exercises, ensure that the scientific integrity and the training effect of the exercises are preserved, but the exercises are implemented as games with motivational features and adaptive difficulty.

Technical justification for HD-tDCS: It has been hypothesized that Gf and ARP are critically dependent on a fronto-parietal brain network, and thus that bilateral, specific stimulation of the frontal cortex with high definition transcranial direct current stimulation (HD-tDCS) would have an excitatory effect on neurons within that network, making them more likely to fire, and thereby enabling faster learning and facilitating transfer to Gf.

Technical Justification for Active Control: Change detection and visual search tasks were selected as the active control tasks because previous work had indicated that training low-level perceptual abilities did not transfer to Gf and ARP.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Bochum Matrices Test
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
Secondary outcomes:
measure: Change in Letter Sets
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Number Series
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Rotation Span
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Symmetry Span
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Reading Span
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Garavan
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Stroop
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Keep Track
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Immediate and Delayed Free Recall - Words
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Immediate and Delayed Free Recall - Pictures
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Paired Associates
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in VO2 Max (relative, percentile)
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Body Mass Index
timeFrame: 2 administrations: within 2 weeks before beginning and after finishing the 16-week intervention period
measure: Change in brain structure
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in BOLD signal at rest
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in BOLD signal during task
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Object Location Task performance
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in 3-back Task performance
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Diffusion of Water in the brain
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in single-voxel magnetic resonance spectroscopy (MRS)
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Cerebral Blood Flow
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Saliva-based Genetic Biomarkers
timeFrame: One administration, within a week after finishing the 16-week intervention
measure: Height
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Weight
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Demographics Questionnaire
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Big Five Inventory (BFI) Questionnaire
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Grit Scale Questionniare
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Godin-Shepard Leisure Time Physical Activity Questionnaire
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in UCLA Loneliness Scale
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Need for Cognition
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Change in Implicit Theories of Intelligence Survey (ITIS)
timeFrame: 2 administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Physical Activity Enjoyment Scale
timeFrame: Administered once, within a week after finishing the 16-week intervention period
measure: Post-Experiment Survey
timeFrame: Administered once, within 2 weeks after finishing the 16-week intervention period
measure: Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q)
timeFrame: Two administrations: within a week before beginning and after finishing the 16-week intervention period
measure: Game Feedback - Mind Frontiers
timeFrame: Administered at Sessions 1, 20 (or 24), and 48 of the Mind Frontiers intervention
measure: Game Feedback - Active Control
timeFrame: Administered at Sessions 1, 24, and 48 of Active Control intervention
measure: Army Physical Readiness Test (APRT)
timeFrame: Administered at Session 1 and Session 28 of the fitness intervention
measure: Heart rate
timeFrame: Data collected continuously during at all 28 fitness intervention sessions
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Aron K Barbey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Arthur F Kramer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Neal J Cohen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Charles H Hillman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Baumgartner, NW, Covello, AR, Reeser, GE, Cohen, NJ, Kramer, AF, Barbey, AK, Hillman, CH, Khan, NA. Moderate to vigorous physical activity influences aerobic capacity independent of body composition. Poster session presented at: American College of Sports Medicine 2016 Conference; 2016 Jun; Boston, MA.
citation: Covello, A, Baumgartner, NW, Curran, MR, Reeser, GE, Cohen, NJ, Kramer, AF, Hillman, CH, Barbey, AK, Khan, NA. The sexual dimorphic relationship between dietary fiber intake and visceral adipose tissue. Abstract accepted to: Experimental Biology 2016 Meeting; 2016 Apr; San Diego, CA.