Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic; Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Task Switching Training; Behavioral: Control Task

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline	2 months

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: New Jersey Commission on Brain Injury Research
• Investigators: Principal Investigator: Starla Weaver, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R-743-12