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

Primary Purpose

Brain Concussion, Post-Concussion Symptoms, Concussion

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3D-MOT Neurotracker
Visual Attention Intervention
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal Children's Hospital, MUHC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental group

Active control group

Control group

Arm Description

Standard care + 3D-MOT protocol.

Standard care + visual attention task (2048 online game)

Standard care alone

Outcomes

Primary Outcome Measures

Post Concussion Symptom Inventory
Post-concussion symptoms checklist

Secondary Outcome Measures

Full Information

First Posted
July 9, 2017
Last Updated
September 11, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03213730
Brief Title
Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Official Title
Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Post-Concussion Symptoms, Concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Standard care + 3D-MOT protocol.
Arm Title
Active control group
Arm Type
Active Comparator
Arm Description
Standard care + visual attention task (2048 online game)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care alone
Intervention Type
Other
Intervention Name(s)
3D-MOT Neurotracker
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Visual Attention Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Concussion Symptom Inventory
Description
Post-concussion symptoms checklist
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Montreal Children's Hospital, MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33201041
Citation
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.
Results Reference
derived

Learn more about this trial

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

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