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Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

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.
 
ClinicalTrials.gov Identifier: NCT01993407
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
New Jersey Commission on Brain Injury Research
Information provided by (Responsible Party):
Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Brain Injuries, Traumatic Behavioral: Task Switching Training Behavioral: Control Task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Task Switching Training
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Behavioral: Task Switching Training
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.

Placebo Comparator: Pure Task Training
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.
Behavioral: Control Task
Participants will complete four, one-hour training sessions in which they will perform a single task each session




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT01993407


Locations
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United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
New Jersey Commission on Brain Injury Research
Investigators
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Principal Investigator: Starla Weaver, PhD Kessler Foundation
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT01993407    
Other Study ID Numbers: R-743-12
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System