INSIGHT, A Comprehensive, Multidisciplinary Brain Training System

NCT02780739 | Completed

• 2 other identifiers: 2014-1312170004-Ph1a14212
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (39)

• Change in Letter Sets

  2 administrations: within a week before beginning and after finishing the 16-week intervention period

• Change in Number Series

  2 administrations: within a week before beginning and after finishing the 16-week intervention period

• Change in Rotation Span

  2 administrations: within a week before beginning and after finishing the 16-week intervention period

• Change in Symmetry Span

  2 administrations: within a week before beginning and after finishing the 16-week intervention period

• Change in Reading Span

  2 administrations: within a week before beginning and after finishing the 16-week intervention period

Study Arms (5)

Cognitive Training - 48 sessions

EXPERIMENTAL

56 hours of video game training with Mind Frontiers adaptive cognitive training software (48 70-min sessions distributed over 16 weeks)

Behavioral: Cognitive Training - 48 sessions

Fitness, Cognitive Training, sham tDCS

EXPERIMENTAL

32 hours and 40 min of high-intensity cardiorespiratory fitness training (28 70-min sessions distributed over 16 weeks); 23 hours and 20 min of video game training with Mind Frontiers adaptive cognitive training software with simultaneous sham tDCS (20 70-min sessions distributed over weeks 5-16)

Behavioral: Fitness; Device: sham tDCS; Behavioral: Cognitive Training - 20 sessions

Fitness, Cognitive Training, active tDCS

EXPERIMENTAL

32 hours and 40 min of high-intensity cardiorespiratory fitness training (28 70-min sessions distributed over 16 weeks); 23 hours and 20 min of video game training with Mind Frontiers 1.0 adaptive cognitive training software with simultaneous active tDCS for a total of 10 hrs (20 70-min sessions distributed over weeks 5-16)

Behavioral: Fitness; Device: active tDCS; Behavioral: Cognitive Training - 20 sessions

Active Control

ACTIVE COMPARATOR

56 hours of video game training with visual search and change detection tasks using open sesame software (48 70-min sessions distributed over 16 weeks)

Behavioral: Active Control

No Contact Control

NO INTERVENTION

Completed no study activities for 16 weeks after pre-assessment, then returned for post-assessment

Interventions

Cognitive Training - 48 sessions BEHAVIORAL

Mind Frontiers cognitive training software (Aptima Inc.) is a Wild West-themed Android application played on Nexus 10 tablets. This intervention includes 20 70-min sessions (23.33 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The 6 mini-games, played in random order for 10 min each session, are Ante Up (Tower of London, executive functioning); Irrigator (visuospatial reasoning); Pen 'Em Up (dual task switching, executive function); Supply Run (Keep Track, working memory updating); Riding Shotgun (visuospatial working memory); and Sentry Duty (dual n-back, working memory). There is also a meta-game in which players build a town using resources earned from the mini-games, played for 5 min each session.

Also known as: Mind Frontiers adaptive cognitive training - 48 sessions

Cognitive Training - 48 sessions

Fitness BEHAVIORAL

Based on high intensity cardiovascular resistance training (HICRT), this intervention includes a combination of aerobic and strength training. Sessions are conducted in a group of ≤20 participants per class, with ≤5 participants per trainer. This intervention includes 28 70-min sessions (32.67 hrs) completed over 16 weeks: 3/wk weeks 1-4, 2/wk weeks 5-8, 1/wk weeks 9-16. At the first and last session, participants complete the Army Physical Readiness Test. All other sessions consist of: Warm-up; Walk/Run; 2 HICRT circuits with 3 sets of 3-4 exercises; 1-2 min jump rope and 4-min power series between HICRT segments; Drills \& Skills; and Cool-down/stretch.

Also known as: high intensity cardiovascular resistance training, aerobic and strength training

Fitness, Cognitive Training, active tDCS; Fitness, Cognitive Training, sham tDCS

Active Control BEHAVIORAL

The active control condition consists of 2 tasks (change detection and visual search) with 3 variants each. This intervention includes 48 70-min sessions (56 hrs) completed over 16 weeks: 3/wk. The 6 tasks are played in random order for 10 min each session.

Also known as: Adaptive Visual Search/Change Detection

Active Control

active tDCS DEVICE

Active HD-tDCS is administered during the first 30 minutes of each Mind Frontiers session. Therefore, the schedule is 20 30-min sessions (10 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The HD-tDCS devices are Soterix Medical 2x2 models, using 4 electrodes (2 anodal and 2 cathodal). Electrodes are held in place with custom, 3D-printed electrode holders inserted into EEG caps, using EEG gel. Participants receive 2.0 mA current for 30 min, split over the 2 anodal electrodes, each drawing ≤1.0 mA. Stimulation is ramped up and ramped down over 30 sec at the beginning and end of the 30-min stimulation period.

Also known as: active high-def transcranial direct current stimulation

Fitness, Cognitive Training, active tDCS

sham tDCS DEVICE

Sham HD-tDCS is administered during the first 30 minutes of each Mind Frontiers session. Therefore, the schedule is 20 30-min sessions (10 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The HD-tDCS devices are Soterix Medical 2x2 models, using 4 electrodes (2 anodal and 2 cathodal). Electrodes are held in place with custom, 3D-printed electrode holders inserted into EEG caps, using EEG gel. Participants do not receive sustained stimulation; it is ramped up and ramped down over 30 sec at the beginning and end of the 30-min stimulation period to elicit the sensation of simulation and make the sham condition more convincing.

Also known as: sham high-definition transcranial direct current stimulation

Fitness, Cognitive Training, sham tDCS

Cognitive Training - 20 sessions BEHAVIORAL

Mind Frontiers cognitive training software (Aptima Inc.) is a Wild West-themed Android application played on Nexus 10 tablets. This intervention includes 20 70-min sessions (23.33 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The 6 mini-games, played in random order for 10 min each session, are Ante Up (Tower of London, executive functioning); Irrigator (visuospatial reasoning); Pen 'Em Up (dual task switching, executive function); Supply Run (Keep Track, working memory updating); Riding Shotgun (visuospatial working memory); and Sentry Duty (dual n-back, working memory). There is also a meta-game in which players build a town using resources earned from the mini-games, played for 5 min each session.

Also known as: Mind Frontiers adaptive cognitive training - 20 sessions

Fitness, Cognitive Training, active tDCS; Fitness, Cognitive Training, sham tDCS

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• The City College of New York: collaborator
• Aptima, Inc.: collaborator
• Georgia Institute of Technology: collaborator
• Circinnus LLC: collaborator
• Autonomous University of Madrid, Spain: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (68)

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  PMID: 26808332 RESULT

• Greenlee, T, Greene, DR, Ward, NJ, Reeser, GE, Allen, CM, Baumgartner, NW, Cohen, NJ, Kramer, AF, Barbey, AK, Hillman, CH. Effectiveness of a 16-Week High Intensity Cardio-Resistance Training (HICRT) Program in young and middle aged adults. Poster session presented at: American College of Sports Medicine 2016 Conference; 2016 Jun 3; Boston, MA.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aron K Barbey, Ph.D.

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

• Arthur F Kramer, Ph.D.

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Neal J Cohen, Ph.D.

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

• Charles H Hillman, Ph.D.

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 23, 2016
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

US (1)