Executive Function Training Intervention for Chronic Traumatic Brain Injury

NCT03704116 | Completed

• 1 other identifier: UTDallas
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic Brain Injury (TBI) is a prevalent disorder developed by military personnel. While some individuals recover function within months after injury, others continue to suffer from cognitive problems months to years later and may not become evident immediately, particularly for the recently transitioned veteran. Chronic TBI cases may include persistent difficulties in cognition that negatively impact employment and personal relationships. The investigators will test and evaluate software-based interventions aimed at improving cognition in veterans experiencing everyday life cognitive deficits due to TBI. The interventions will be administered on a computer using a tele-health approach. Two conditions will be compared, an active condition challenging memory, inhibitory control and planning, and a context-matched control condition that is lower on these challenge levels.

Conditions

Traumatic Brain Injury

Keywords

chronic traumatic brain injury; cognition; executive function

Outcome Measures

Primary Outcomes (1)

• Virtual Multiple Errands Test

  executive function measure carried out in computer simulation of shopping market

  change is evaluated from the beginning of the intervention to after completion (1 month in between)

Secondary Outcomes (4)

• Resting-State functional Magnetic Resonance Imaging (fMRI)

  change is evaluated from the beginning of the intervention to after completion (1 month in between)

• Task-based functional Magnetic Resonance Imaging (fMRI)

  change is evaluated from the beginning of the intervention to after completion (1 month in between)

• Automated Neuropsychological Assessement Metrics (ANAM)

  change is evaluated from the beginning of the intervention to after completion (1 month in between)

• Traumatic Brain Injury (TBI) Awareness Questionnaire

  change is evaluated from the beginning of the intervention to after completion (1 month in between)

Study Arms (2)

Expedition: Strategic Advantage

ACTIVE COMPARATOR

Software-based intervention simulating daily life cognitive challenges. Delivered 1 hour per day, 5 days per week for 4 weeks. Includes 8 check-in phone calls with an experimenter. Includes escalating challenge levels.

Behavioral: Expedition

Expedition: Informational Advantage

PLACEBO COMPARATOR

Software-based intervention simulating daily life cognitive challenges. Delivered 1 hour per day, 5 days per week for 4 weeks. Includes 8 check-in phone calls with an experimenter. Includes capped challenge levels.

Behavioral: Expedition

Interventions

Expedition BEHAVIORAL

On a laptop computer participants work on simulated daily life activities including packing for a trip, navigating a transit system, and learning at museum attractions. The intervention increases difficulty as participants accomplish goals. We are testing the effects of this performance challenge on executive function measures.

Expedition: Informational Advantage; Expedition: Strategic Advantage

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male and female military veteran adults between the ages of 19 to 55 years (served in the military (any branch))
• who have sustained a traumatic brain injury at least 3 months previously
• who can comprehend simple instructions, perform the tests, and take part in the intervention training
• Selection criteria will also include participants who can safely have an MRI, who can tolerate at least 2 hours of intervention sessions at a time, and who can participate in tasks involving motor abilities such as use of at least one arm and hand
• No racial/ethnic groups will be excluded, although the patients must be able to speak, read, and comprehend English well enough to participate in the testing and treatment sessions, since the assessments are not normed or translated in other languages at this time.

You may not qualify if:

• someone who is not proficient in reading, comprehending, and speaking English,
• has pre-existing cerebral palsy, mental retardation, autism, epilepsy, schizophrenia, or pervasive developmental disorder.
• Individuals with psychosis, active behavioral disorder, or uncontrolled epilepsy will be excluded.
• Pregnant women will be excluded, since the effects of the treatment or the procedures on a fetus are unknown.

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Applied Research Associates, Inc: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

The University of Texas at Dallas Center for BrainHealth

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Krawczyk DC, Han K, Martinez D, Rakic J, Kmiecik MJ, Chang Z, Nguyen L, Lundie M, Cole RC, Nagele M, Didehbani N. Executive function training in chronic traumatic brain injury patients: study protocol. Trials. 2019 Jul 15;20(1):435. doi: 10.1186/s13063-019-3526-x.

  PMID: 31307502 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

CHE protein, Arabidopsis

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marcia Clover

  Applied Research Associates

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Debbie and Jim Francis Chair

Model Details: Two groups run in parallel (active and control)

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: October 12, 2018
• Study Start: July 16, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)