Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

NCT ID: NCT01993407

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Traumatic Brain Injury; Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Task Switching Training

Intervention Type: BEHAVIORAL

Participants 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

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.

Group Type: PLACEBO_COMPARATOR

Control Task

Intervention Type: BEHAVIORAL

Participants will complete four, one-hour training sessions in which they will perform a single task each session

Interventions

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.

Intervention Type: BEHAVIORAL

Control Task

Participants will complete four, one-hour training sessions in which they will perform a single task each session

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Jersey Commission on Brain Injury Research

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Starla Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation Research Center

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

R-743-12

Identifier Type: -

Identifier Source: org_study_id