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Trial record 17 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy)

Executive Function Training Intervention for Chronic Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03704116
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Applied Research Associates, Inc
Information provided by (Responsible Party):
Dan Krawczyk, The University of Texas at Dallas

Tracking Information
First Submitted Date  ICMJE July 3, 2018
First Posted Date  ICMJE October 12, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE July 16, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Virtual Multiple Errands Test [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
executive function measure carried out in computer simulation of shopping market
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03704116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Resting-State functional Magnetic Resonance Imaging (fMRI) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional connectivity assessment
  • Task-based functional Magnetic Resonance Imaging (fMRI) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional brain imaging attention task
  • Automated Neuropsychological Assessement Metrics (ANAM) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing
  • Traumatic Brain Injury (TBI) Awareness Questionnaire [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    Survey measure asking for estimate of current symptoms compared to before brain injury
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Resting-State fMRI [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional connectivity assessment
  • Task-based fMRI [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional brain imaging attention task
  • ANAM Automated Neuropsychological Assessement Metrics [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing
  • TBI Awareness Questionnaire [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    Survey measure asking for estimate of current symptoms compared to before brain injury
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Executive Function Training Intervention for Chronic Traumatic Brain Injury
Official Title  ICMJE Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury
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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups run in parallel (active and control)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Double-blinded
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Behavioral: Expedition
  • Placebo Comparator: 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.
    Intervention: Behavioral: Expedition
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Krawczyk, PhD 9728833234 daniel.krawczyk@utdallas.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03704116
Other Study ID Numbers  ICMJE UTDallas
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dan Krawczyk, The University of Texas at Dallas
Study Sponsor  ICMJE The University of Texas at Dallas
Collaborators  ICMJE Applied Research Associates, Inc
Investigators  ICMJE Not Provided
PRS Account The University of Texas at Dallas
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP