NCT03582579

Brief Summary

The purpose of this study is to evaluate the effectiveness of brain training in a Virtual Reality set up in neurotypical populations as well as in the traumatic brain injury population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

March 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

7.2 years

First QC Date

March 20, 2018

Last Update Submit

July 3, 2024

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

  • Visual Crowding (a measure of spacial resolution of attention)

    This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.

    6 weeks

  • Attentional Blink (a measure of temporal resolution of attention)

    This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.

    6 weeks

  • Useful Field of View (a measure of spacial awareness)

    This is a visual task which will be done an a computer twice. Once prior to the start of training and then again following training. The results (including the number of trials correct as well as the time it took for the subject to respond) will be analyzed and compared across groups.

    6 weeks

Study Arms (4)

Control in VR

EXPERIMENTAL

Adults ages 18 to 35 who will be training in Virtual Reality.

Behavioral: Training in Virtual Reality

Control Non-VR

EXPERIMENTAL

Adults ages 18 to 35 who will be training on a computer screen.

Behavioral: Training on a computer screen

College Athletes with TBI Group

EXPERIMENTAL

Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality

Behavioral: Training in Virtual Reality

Older Adult Group

EXPERIMENTAL

Older Adults over the age of 65 who will be training in Virtual Reality

Behavioral: Training in Virtual Reality

Interventions

Training in Virtual RealityBEHAVIORAL

Action Video Game Based Training in Virtual Reality

College Athletes with TBI GroupControl in VROlder Adult Group
Training on a computer screenBEHAVIORAL

Action Video Game Based Training on a computer screen

Control Non-VR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is an adult over the age of 18.
  • Has the capacity to give consent.
  • Has normal or corrected to normal vision.
  • Has adequate hearing.
  • Is a non-action video game player.
  • Is a non-VR game player. All subjects will be assigned to one of four groups: a Control Group training in VR, a Control Groups training on a 2D display, an Older Adult Group without dementia training in VR, and a College Athletes with mild TBI Group training in VR.
  • Be between the ages of 18 and 35.
  • Have no neurologic or vascular disorders/injuries.
  • Be between the ages of 18 and 35.
  • Be diagnosed with mild TBI (i.e., concussion) within the last two weeks.
  • Be over the age of 65.
  • Have no neurologic or vascular disorders/injuries.

You may not qualify if:

  • A person will be excluded from the study if he/she:
  • Is under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Duje Tadin, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2018

First Posted

July 11, 2018

Study Start

June 27, 2018

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

US(1)