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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Isabelle Gagnon, McGill University Health Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT03213730
First received: July 9, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
  Purpose
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).

Condition Intervention
Brain Concussion Post-Concussion Symptoms Concussion Other: 3D-MOT Neurotracker Other: Visual Attention Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery

Resource links provided by NLM:


Further study details as provided by Isabelle Gagnon, McGill University Health Center:

Primary Outcome Measures:
  • Post Concussion Symptom Inventory [ Time Frame: 1 month ]
    Post-concussion symptoms checklist


Estimated Enrollment: 90
Actual Study Start Date: January 10, 2017
Estimated Study Completion Date: July 30, 2019
Estimated Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control group
Standard care alone

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03213730

Contacts
Contact: Isabelle Gagnon, PhD 514-412-4400 ext 23896

Locations
Canada, Quebec
Montreal Children's Hospital, MUHC Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Isabelle Gagnon, PhD    514-412-4400 ext 23896    isabelle.gagnon8@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Isabelle Gagnon, Clinical Scientist, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03213730     History of Changes
Other Study ID Numbers: 13-146-PED
Study First Received: July 9, 2017
Last Updated: July 9, 2017

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

Additional relevant MeSH terms:
Brain Injuries
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Post-Concussion Syndrome
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017