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

NCT03213730 | Completed

• 1 other identifier: 13-146-PED
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Concussion; Post-Concussion Symptoms; Concussion

Outcome Measures

Primary Outcomes (1)

• Post Concussion Symptom Inventory

  Post-concussion symptoms checklist

  1 month

Study Arms (3)

Experimental group

EXPERIMENTAL

Standard care + 3D-MOT protocol.

Other: 3D-MOT Neurotracker

Active control group

ACTIVE COMPARATOR

Standard care + visual attention task (2048 online game)

Other: Visual Attention Intervention

Control group

NO INTERVENTION

Standard care alone

Interventions

3D-MOT Neurotracker OTHER

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.

Experimental group

Visual Attention Intervention OTHER

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.

Active control group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Montreal Children's Hospital, MUHC

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (1)

• 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.

  PMID: 33201041 DERIVED

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 11, 2017
• Study Start: January 10, 2017
• Primary Completion: March 1, 2019
• Study Completion: August 30, 2019
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CA (1)