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Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.

Primary Purpose

Traumatic Brain Injury, Concussion, Mild Cognitive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psycho-Social Therapy
Cognitive Behavioral Computer Training
Interactive Trainer-Subject Sessions
Active Control Games
Sponsored by
Brain & Body Health Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring NFL, veterans, cognitive training, TBI, concussion

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • History of >1 Mild TBI: post traumatic amnesia/confusion ≤ 24 hour immediately after injury; or loss of consciousness <30 min confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
  • Age 25-55 years
  • Minimum of 4 months post-injury
  • Adequate visual, auditory, sensory-motor function for training program.
  • Fluent in English
  • Persistent cognitive dysfunction confirmed by Ruff Neurobehavioral Inventory score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive).

Exclusion Criteria:

  • History of hypoxic event
  • Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
  • Current illicit drug use or alcohol abuse
  • Unwilling or unable (e.g. language barrier) to participate
  • Hospitalization during study
  • Current Litigation
  • Positive on malingering test
  • Use of medications to enhance cognitive function (e.g. Ritalin)
  • Initial Glasgow Coma Score < 13 or penetrating head injury
  • Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale. Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
  • Subjects should not be enrolled in a concurrent TBI clinical trial.

Sites / Locations

  • Brain & Body Health Institute, P.A.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Individual + Computer A

Individual + Computer B

Group + Computer B

Arm Description

Daily activities involve playing one hour of computer games (e.g., hangman, boggle, word scramble, chess; computer cognitive training A (CCA)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information.

Daily activities involve playing an alternative set of computer games (computer cognitive training B (CCB)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information.

Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).

Outcomes

Primary Outcome Measures

Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.
Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.
Participant reported outcomes
Measure of impact of program use on the patient's own view of their impairment and function.
Working/school status
Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.
Exercise-base assessments
Four sets of assessments that are closely modeled on study-related exercises in the auditory, visual, cognitive, and social-cognitive modules. These include auditory speed of processing, visual speed of processing, cognitive control speed of processing and face recognition, recall of unique faces, and emotional cue recognition.
Functional assessments
Timed instrumental activities of daily living (TIADL) and the Mayo-Portland Adaptability Inventory (MPAI-4) for sensitive directly observed performance and well-accepted clinical impression measures.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2016
Last Updated
March 3, 2016
Sponsor
Brain & Body Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02699476
Brief Title
Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
Official Title
Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brain & Body Health Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare different combinations of cognitive training in retired professional football players and military veterans with a history of repeated concussions and persistent symptoms of impaired memory, concentration, attention, focus, or thinking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Concussion, Mild Cognitive Disorder
Keywords
NFL, veterans, cognitive training, TBI, concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual + Computer A
Arm Type
Active Comparator
Arm Description
Daily activities involve playing one hour of computer games (e.g., hangman, boggle, word scramble, chess; computer cognitive training A (CCA)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information.
Arm Title
Individual + Computer B
Arm Type
Experimental
Arm Description
Daily activities involve playing an alternative set of computer games (computer cognitive training B (CCB)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information.
Arm Title
Group + Computer B
Arm Type
Active Comparator
Arm Description
Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).
Intervention Type
Behavioral
Intervention Name(s)
Psycho-Social Therapy
Intervention Type
Device
Intervention Name(s)
Cognitive Behavioral Computer Training
Other Intervention Name(s)
BrainHQ
Intervention Type
Behavioral
Intervention Name(s)
Interactive Trainer-Subject Sessions
Other Intervention Name(s)
LearningRx
Intervention Type
Device
Intervention Name(s)
Active Control Games
Primary Outcome Measure Information:
Title
Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.
Description
Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.
Time Frame
within one week following treatment completion
Title
Participant reported outcomes
Description
Measure of impact of program use on the patient's own view of their impairment and function.
Time Frame
within one week following treatment completion.
Title
Working/school status
Description
Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.
Time Frame
within one week following treatment completion.
Title
Exercise-base assessments
Description
Four sets of assessments that are closely modeled on study-related exercises in the auditory, visual, cognitive, and social-cognitive modules. These include auditory speed of processing, visual speed of processing, cognitive control speed of processing and face recognition, recall of unique faces, and emotional cue recognition.
Time Frame
within one week following treatment completion.
Title
Functional assessments
Description
Timed instrumental activities of daily living (TIADL) and the Mayo-Portland Adaptability Inventory (MPAI-4) for sensitive directly observed performance and well-accepted clinical impression measures.
Time Frame
within one week following treatment completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of >1 Mild TBI: post traumatic amnesia/confusion ≤ 24 hour immediately after injury; or loss of consciousness <30 min confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF). Age 25-55 years Minimum of 4 months post-injury Adequate visual, auditory, sensory-motor function for training program. Fluent in English Persistent cognitive dysfunction confirmed by Ruff Neurobehavioral Inventory score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive). Exclusion Criteria: History of hypoxic event Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders. Current illicit drug use or alcohol abuse Unwilling or unable (e.g. language barrier) to participate Hospitalization during study Current Litigation Positive on malingering test Use of medications to enhance cognitive function (e.g. Ritalin) Initial Glasgow Coma Score < 13 or penetrating head injury Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale. Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment. Subjects should not be enrolled in a concurrent TBI clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert W Van Boven, M.D., D.D.S.
Phone
512-981-5801
Email
brainbodyhealthfoundation@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark R Taylor, Ph.D.
Phone
586-945-6618
Email
mtaylormich@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Van Boven, M.D., D.D.S.
Organizational Affiliation
Brain & Body Health Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain & Body Health Institute, P.A.
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.

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