Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03213730
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Center

Brief Summary:
This study is part of a larger, multi-centered project done with the collaboration of University Of Victoria. This study holds three separate studies on the mild traumatic brain injured population and the use of perceptual-cognitive training (3D-MOT).

Condition or disease Intervention/treatment Phase
Brain Concussion Post-Concussion Symptoms Concussion Other: 3D-MOT Neurotracker Other: Visual Attention Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental group
Standard care + 3D-MOT protocol.
Other: 3D-MOT Neurotracker
A predetermined number of spheres (eight) are presented in the 3D-MOT task. The spheres are all identical in shape and color. Before each trial, four spheres are highlighted, and then returned to their original color. Participants will be asked to track those four spheres for the duration of the trial (8 seconds). Spheres will be moving, bouncing, colliding, until they finally stop moving and the participant has to identify the spheres that were initially highlighted. Previous work with healthy individuals has shown that the minimum optimal number of sessions (3 blocks) necessary to induce brain plasticity and enhance other, "non-trained" brain functions is between 5-6. The training protocol will therefore include 6 sessions (3 blocks each), at intervals of 48 to 72 hours, over a maximum of 3 weeks.

Active Comparator: Active control group
Standard care + visual attention task (2048 online game)
Other: Visual Attention Intervention
The visual attention intervention will consist of the 2048 game, a single-player sliding block puzzle game of which the objective is to slide numbered tiles on a grid to combine them to create number 2048. 2048 is played on a gray 4×4 grid, with numbered tiles that slide smoothly when a player moves them using the four arrow keys. Every turn, a new tile will randomly appear in an empty spot on the board with a value of either 2 or 4.Tiles slide as far as possible in the chosen direction until they are stopped by either another tile or the edge of the grid. If two tiles of the same number collide while moving, they will merge into a tile with the total value of the two tiles that collided. Higher-scoring tiles emit a soft glow. Children will play for a time equivalent to that of the 3D-MOT.

No Intervention: Control group
Standard care alone

Primary Outcome Measures :
  1. Post Concussion Symptom Inventory [ Time Frame: 1 month ]
    Post-concussion symptoms checklist

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The child experienced a head injury (a direct or indirect blow to the head) resulting in concussion-like symptoms (e.g. headache, nausea, balance problems, tiredness, visual problems, cognitive issues) in the previous 72 hours
  • Parent/legal guardian speak English or French
  • The child speak English or French

Exclusion Criteria:

  • Previous concussion in the last 6 months, or any previous concussion with unresolved symptoms
  • Multi-system injuries requiring admission, operating room, procedural sedation in the Emergency Department
  • Other co-existing injuries, co-morbidities or diagnoses preventing participation to intervention/assessment of gait and balance
  • Pre-morbid or co-morbid condition affecting visual function
  • Patient intoxicated at the time of injury
  • Significant developmental delay
  • Loss of consciousness prior to head injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03213730

Contact: Isabelle Gagnon, PhD 514-412-4400 ext 23896

Canada, Quebec
Montreal Children's Hospital, MUHC Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Isabelle Gagnon, PhD    514-412-4400 ext 23896   
Sponsors and Collaborators
McGill University Health Center
Merck Sharp & Dohme Corp.

Responsible Party: Isabelle Gagnon, Clinical Scientist, McGill University Health Center Identifier: NCT03213730     History of Changes
Other Study ID Numbers: 13-146-PED
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Post-Concussion Syndrome
Central Nervous System Diseases
Nervous System Diseases