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

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).

Study Overview

• Status: Completed
• Conditions: Brain Concussion; Concussion; Post-Concussion Symptoms
• Intervention / Treatment: Other: 3D-MOT Neurotracker; Other: Visual Attention Intervention

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • Montreal Children's hospital, MUHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard care alone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Concussion Symptom Inventory	Post-concussion symptoms checklist	1 month

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Teel E, Brossard-Racine M, Corbin-Berrigan LA, Gagnon I. Perceptual Cognitive Training Does Not Improve Clinical Outcomes at 4 and 12 Weeks Following Concussion in Children and Adolescents: A Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Mar-Apr 01;36(2):E97-E107. doi: 10.1097/HTR.0000000000000633.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 13-146-PED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No