Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

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. Read our disclaimer for details. Identifier: NCT01414348
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
Deirdre Dawson, Baycrest

Brief 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Cerebrovascular Accident (CVA) Acquired Brain Injury Behavioral: Conventional rehabilitation. Behavioral: Novel rehabilitation approach Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach
Study Start Date : March 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Conventional rehabilitation
In-home work on problems in daily living.
Behavioral: Conventional rehabilitation.
1 hour / 2x / week for up to 15 sessions

Experimental: Novel rehabilitation approach Behavioral: Novel rehabilitation approach
1 hr, 2x/week for up to 15 sessions

Primary Outcome Measures :
  1. Change in performance on COPM [ Time Frame: pre, post, 3 month follow-up ]
    Canadian Occupational Performance Measure: standardized interview

Secondary Outcome Measures :
  1. DEX, IADL profile [ Time Frame: pre, post, 3 month follow-up ]
    Perceived and observed impact of dysexecutive syndrome in everyday life

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT01414348

Canada, Ontario
Baycrest Centre for Geriatric Care
Toronto, Ontario, Canada, M6A2E1
Sponsors and Collaborators
Principal Investigator: Deirdre D Dawson, PhD Baycrest centre

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest Identifier: NCT01414348     History of Changes
Other Study ID Numbers: REB1120
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Deirdre Dawson, Baycrest:
activities of daily living
brain injuries
executive function

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases