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Completed

NCT Number: NCT02792296

Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

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.

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Key information

Conditions

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preferred Research Partners, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Project: EVO Monitor

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.

Primary outcomes

  1. Feasibility of at-home use as measured by percent of completed assigned sessions

    Time frame: 4 to 8 weeks

Sponsors and collaborators

Lead sponsor

Akili Interactive Labs, Inc.

Industry

Registry information

Official study title

A Study to Assess the Feasibility of and to Characterize Project: EVO Monitor Cognitive Function Measurements When Played Daily, Weekly, or Multiple Times Per Day in Adults 40-55 Years Old

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2016
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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