Executive Function Training Intervention for Chronic Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2021-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remotely Deployed TBI Study

NCT01882244

Brain Injury

UNKNOWN NA

Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

NCT04245124

Mild Traumatic Brain Injury

UNKNOWN NA

Brain Training to Enhance Frontal Lobe Reasoning

NCT01552473

Traumatic Brain Injury

COMPLETED NA

Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

NCT01921179

Post Traumatic Stress Disorder Mild Traumatic Brain Injury, Concussion

COMPLETED NA

PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

NCT00927576

Traumatic Brain Injury

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will evaluate the improvement of chronic TBI symptoms after interventions. The investigators will evaluate the improvement of chronic mTBI symptoms using Magnetic Resonance Imaging (MRI)-based injury markers, cognitive functions, and real-world functioning questionnaires.

The investigators will recruit military veterans with mild-to-moderate chronic TBI (at least 3 months post injury). The investigators will gather neuropsychological, cognitive, and neuroimaging (functional MRI, resting-state functional MRI) measures. The efficacy of the active compared to control intervention will be evaluated in 100 chronic TBI veterans. All participants will be randomized to a group to complete four weeks of intervention over 20 performance sessions. Over the course of training participants will face escalating challenges in each of these domains, thereby improving their overall skills. The software captures response times and accuracy of performance throughout each task. Evaluations of cognition (neuropsychological testing), brain (MRI), real life functional ability (survey data), and real life performance data (multiple errands tasks) will be gathered pre- and post-intervention to evaluate cognitive, brain-based, and real life functional improvements.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups run in parallel (active and control)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double-blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Expedition: Strategic Advantage

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.

Group Type ACTIVE_COMPARATOR

Expedition

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Expedition

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Expedition

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
* Also, we will screen for possible Post Traumatic Stress Disorder (PTSD) using the Mississippi PTSD Questionnaire, but it will not be an exclusionary criteria.

Exclusion Criteria

* 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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No