Early Intervention Following Mild TBI

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947504
• Other study ID #: 3525
• Secondary ID: MUHC
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Mild TBI

Exclusion Criteria:

• Psychiatric diagnosis

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• education and support intervention

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Elaine De Guise	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of post-concussive symptoms		1 year