Back to resultsTraining Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury, Brain Injuries, Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Task Switching Training
Control Task
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
- If you are between the ages of 19 and 65.
Exclusion Criteria:
For participants with Traumatic Brain Injury:
- If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
- If your Brain injury is less than 6 months ago.
For healthy participants:
-If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).
For All participants:
- If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
- If you have a alcohol or drug abuse history.
- If you are currently taking certain types of medications, which the study doctor will review.
- If you do not have a working knowledge of the English Language.
Sites / Locations
- Kessler Foundation Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Task Switching Training
Pure Task Training
Arm Description
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Participants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions.
Outcomes
Primary Outcome Measures
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01993407
First Posted
November 13, 2013
Last Updated
August 8, 2018
Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
1. Study Identification
Unique Protocol Identification Number
NCT01993407
Brief Title
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Official Title
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Brain Injuries, Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Task Switching Training
Arm Type
Experimental
Arm Description
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Arm Title
Pure Task Training
Arm Type
Placebo Comparator
Arm Description
Participants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions.
Intervention Type
Behavioral
Intervention Name(s)
Task Switching Training
Intervention Description
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Intervention Type
Behavioral
Intervention Name(s)
Control Task
Intervention Description
Participants will complete four, one-hour training sessions in which they will perform a single task each session
Primary Outcome Measure Information:
Title
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
If you are between the ages of 19 and 65.
Exclusion Criteria:
For participants with Traumatic Brain Injury:
If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
If your Brain injury is less than 6 months ago.
For healthy participants:
-If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).
For All participants:
If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
If you have a alcohol or drug abuse history.
If you are currently taking certain types of medications, which the study doctor will review.
If you do not have a working knowledge of the English Language.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Starla Weaver, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation Research Center
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
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