NCT02792296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

June 2, 2016

Last Update Submit

November 3, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    4 to 8 weeks

Study Arms (3)

Daily measurement

EXPERIMENTAL

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

Other: Project: EVO Monitor

Multiple times per day measurement

EXPERIMENTAL

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.

Other: Project: EVO Monitor

Weekly measurement

EXPERIMENTAL

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

Other: Project: EVO Monitor

Interventions

Project: EVO MonitorOTHER

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.

Daily measurementMultiple times per day measurementWeekly measurement

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Ted Riley

    Promedica International

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)