Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 10, 2018
August 1, 2018
3 years
November 13, 2013
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Task Switching Training
EXPERIMENTALParticipants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Pure Task Training
PLACEBO COMPARATORParticipants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- New Jersey Commission on Brain Injury Researchcollaborator
Study Sites (1)
Kessler Foundation Research Center
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Starla Weaver, PhD
Kessler Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2013
First Posted
November 25, 2013
Study Start
June 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 10, 2018
Record last verified: 2018-08