Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

NCT ID: NCT02792296

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-11-30

Brief Summary

This is an open-label study in adults to assess at-home Project: EVO Monitor measurements over repeat play cycles. The study has three arms:playing multiple times per day, once daily, and once weekly for 4 to 8 weeks.

Detailed Description

This is an open-label study in adults ages 40 to 55 to assess Project: EVO Monitor measurements over repeat play cycles. The study has three arms: adults playing multiple times per day, adults playing once daily, and adults playing once weekly. The investigators plan to evaluate 76 participants (N = 30 in the daily and weekly arms, and N=16 in the multiple times per day arm) in two sites over a 4 to 8 week study period. The study period includes 2 in-clinic sessions and scheduled, at-home game play of the short (less than 7 minutes) Project: EVO Monitor.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Daily measurement

This arm will be asked to use the Project: EVO Monitor once a day for four weeks..

Group Type: EXPERIMENTAL

Project: EVO Monitor

Intervention Type: OTHER

Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

Multiple times per day measurement

This arm will be asked to use the Project: EVO Monitor at least once per day and six times over the day every three days for four weeks.

Group Type: EXPERIMENTAL

Project: EVO Monitor

Intervention Type: OTHER

Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

Weekly measurement

This arm will be asked to use the Project: EVO Monitor once a week for eight weeks.

Group Type: EXPERIMENTAL

Project: EVO Monitor

Intervention Type: OTHER

Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

Interventions

Project: EVO Monitor

Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 40-55 at the time of informed consent
• Ability to follow written and verbal instructions (English).
• Male and Female (Gender-matched).
• Ability to comply with all the testing and requirements.

Exclusion Criteria

• Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
• Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
• Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
• Current subjective complaints of inattention or memory loss.
• Current use of psychotropic medication, prescription or otherwise.
• Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
• Motor condition that prevents game playing, as observed by investigator.
• Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
• Recent history (within the past 6 months) of suspected substance abuse or dependence.
• History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
• Taken part in a clinical trial within 30 days prior to screening.
• Diagnosis of color blindness.
• Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments
• Any other medical condition that in the opinion of the investigator may confound study data/assessments.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akili Interactive Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ted Riley

Role: STUDY_DIRECTOR

Promedica International

Locations

Preferred Research Partners

Little Rock, Arkansas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Countries

United States

Other Identifiers

Akili-026

Identifier Type: -

Identifier Source: org_study_id