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Early Intervention Following Mild TBI

This study is currently recruiting participants.
Verified March 2017 by Elaine De Guise, McGill University Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01947504
First Posted: September 20, 2013
Last Update Posted: March 23, 2017
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.
Information provided by (Responsible Party):
Elaine De Guise, McGill University Health Center
  Purpose
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 Intervention
Mild Traumatic Brain Injury Behavioral: eudcation and support intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Elaine De Guise, McGill University Health Center:

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

Estimated Enrollment: 60
Study Start Date: January 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Clinical diagnosis of Mild TBI

Exclusion Criteria:

  • Psychiatric diagnosis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01947504


Locations
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Elaine de Guise, Ph.D.    514-343-6111 ext 53078    elaine.de.guise@umontreal.ca   
Contact: Selma Greffou, Ph.D.    514-934-1934 ext 42610    selma.greffou@muhc.mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
  More Information

Responsible Party: Elaine De Guise, Assistant professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01947504     History of Changes
Other Study ID Numbers: 3525
MUHC ( Other Identifier: MUHC )
First Submitted: September 17, 2013
First Posted: September 20, 2013
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