Early Intervention Following Mild TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01947504
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
Elaine De Guise, McGill University Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Mild Traumatic Brain Injury Behavioral: eudcation and support intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: education and support intervention
education and support intervention
Behavioral: eudcation and support intervention
No Intervention: waiting list
waiting list and regular medical follow-up

Primary Outcome Measures :
  1. Recurrence of post-concussive symptoms [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Mild TBI

Exclusion Criteria:

  • Psychiatric diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01947504

Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Elaine de Guise, Ph.D.    514-343-6111 ext 53078   
Contact: Selma Greffou, Ph.D.    514-934-1934 ext 42610   
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Elaine De Guise, Assistant professor, McGill University Health Center Identifier: NCT01947504     History of Changes
Other Study ID Numbers: 3525
MUHC ( Other Identifier: MUHC )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

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