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Clinical Trials/NCT01993407
NCT01993407CompletedNot Applicable

Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

Kessler Foundation2 sites in 1 country28 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
2
Primary Endpoint
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Task Switching Training

Experimental

Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.

Intervention: Task Switching Training (Behavioral)

Pure Task Training

Placebo Comparator

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: Control Task (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kessler Foundation
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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