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

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213730
• Other study ID #: 13-146-PED
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion
• Post-Concussion Symptoms
• Post-Concussion Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital, MUHC	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Concussion Symptom Inventory	Post-concussion symptoms checklist	1 month