Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Traumatic Brain Injury Clinical Trial

Official title:

Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414348
• Other study ID #: REB1120
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: January 26, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.

Description:

Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• fluent in written and spoken English,

• have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke,

Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebrovascular Accident (CVA)
• Stroke
• Traumatic Brain Injury

Intervention

Behavioral:
• Conventional rehabilitation.
1 hour / 2x / week for up to 15 sessions
• Novel rehabilitation approach
1 hr, 2x/week for up to 15 sessions

Locations

Country	Name	City	State
Canada	Baycrest Centre for Geriatric Care	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in performance on COPM	Canadian Occupational Performance Measure: standardized interview	pre, post, 3 month follow-up	No
Secondary	DEX, IADL profile	Perceived and observed impact of dysexecutive syndrome in everyday life	pre, post, 3 month follow-up	No