Early Intervention Following Mild TBI

The objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H3G1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Mild TBI

Exclusion criteria

Psychiatric diagnosis

Treatment and study plan

education and support intervention

Behavioral

Primary outcomes

Recurrence of post-concussive symptoms

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Elaine De Guise

Other

Collaborators

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

Registry information

Official study title

Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 20, 2013
Registry last updated: Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed