Brain Training to Enhance Frontal Lobe Reasoning

NCT01552473 | Completed Results DMC

• 1 other identifier: STU 032011-191
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

Conditions

Traumatic Brain Injury

Keywords

TBI; Traumatic Brain Injury; combat related injury; blast injury; concussion; sleep problems; attention problems; memory problems; headaches; dizziness; OEF; OIF; Veterans; Civilian

Outcome Measures

Primary Outcomes (6)

• Glasgow Outcome Scale-Extended

  Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.

  Pre-training (Baseline) Neuropsychological Test

• Community Integration Questionnaire

  To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.

  Neuropsychological changes from baseline to 10 weeks post-training

• Functional Status Exam

  To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.

  Measure at 10 weeks post-training

• Daneman-Carpenter Reading Span Test

  Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.

  Measure at 10 weeks post-training

• Hayling Sentence Completion Test

  To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.

  Measure at 10 weeks post-training

• Awareness Questionnaire

  To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.

  Measure at 10 weeks post-training

Secondary Outcomes (12)

• Network Based Statistics in Brain Connectivity

  MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number

• Beck Depression Inventory (BDI)

  Measure taken at 10 weeks post-training

• Post Traumatic Stress Disorder (PTSD) Checklist

  Measure taken at 10 weeks post-training

• Alcohol, Smoking and Substance Involvement Screening Test

  Measure taken at 10 weeks post-training

• Alcohol Use Disorders Identification Test

  Measure taken at 10 weeks post-training

Study Arms (2)

Brain Training Program 1

ACTIVE COMPARATOR

Training Program focusing on providing educational information of cognitive issues related to TBI

Behavioral: Brain Training Program 1

Brain Training Program 2

EXPERIMENTAL

Program focuses on strategies to address cognitive issues following TBI

Behavioral: Brain Training Program 2

Interventions

Brain Training Program 1 BEHAVIORAL

The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.

Brain Training Program 1

Brain Training Program 2 BEHAVIORAL

The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.

Brain Training Program 2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Sustained a traumatic brain injury at least 6 months previously
• Comprehend simple instructions, perform tasks and take part in intervention
• Read, speak and comprehend English
• Participate in tasks involving motor abilities such as use of at least one arm or hand

You may not qualify if:

• Not proficient in reading, comprehending or speaking English
• Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
• Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
• Women who are pregnant

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Center for BrainHealth

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Krawczyk DC, Marquez de la Plata C, Schauer GF, Vas AK, Keebler M, Tuthill S, Gardner C, Jantz T, Yu W, Chapman SB. Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol. Trials. 2013 Jan 30;14:29. doi: 10.1186/1745-6215-14-29.

  PMID: 23363480 DERIVED

Related Links

• Center for BrainHealth

MeSH Terms

Conditions

Brain Injuries, Traumatic; Blast Injuries; Brain Concussion; Parasomnias; Memory Disorders; Headache; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Barotrauma; Head Injuries, Closed; Wounds, Nonpenetrating; Sleep Wake Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Sensation Disorders

Results Point of Contact

• Title: Dr. Daniel Krawczyk, Primary Investigator
• Organization: The University of Texas at Dallas, Center for BrainHealth

dck061000@utdallas.edu

214-905-3007

Study Officials

• Daniel Krawcyzk, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)