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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02699476
• Other study ID #: BBHF-001
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2016
• Last updated: March 3, 2016
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Brain & Body Health Foundation
• Contact: Robert W Van Boven, M.D., D.D.S.
• Phone: 512-981-5801
• Email: brainbodyhealthfoundation[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Cognition Disorders
• Concussion
• Mild Cognitive Disorder
• Mild Cognitive Impairment
• Traumatic Brain Injury

Intervention

Behavioral:
• Psycho-Social Therapy

Device:
• Cognitive Behavioral Computer Training

Behavioral:
• Interactive Trainer-Subject Sessions

Device:
• Active Control Games

Locations

Country	Name	City	State
United States	Brain & Body Health Institute, P.A.	Lakeway	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brain & Body Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within one week following treatment completion	No
Primary	Participant reported outcomes	Measure of impact of program use on the patient's own view of their impairment and function.	within one week following treatment completion.	No
Primary	Working/school status	Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.	within one week following treatment completion.	No
Primary	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.	within one week following treatment completion.	No
Primary	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.	within one week following treatment completion.	No