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

NCT ID: NCT03213730

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2019-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Standard care + 3D-MOT protocol.

Group Type: EXPERIMENTAL

3D-MOT Neurotracker

Intervention Type: 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.

Active control group

Standard care + visual attention task (2048 online game)

Group Type: ACTIVE_COMPARATOR

Visual Attention Intervention

Intervention Type: 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.

Control group

Standard care alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Isabelle Gagnon

Clinical Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montreal Children's Hospital, MUHC

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33201041 (View on PubMed)

Other Identifiers

13-146-PED

Identifier Type: -

Identifier Source: org_study_id