Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

NCT02589509 | Withdrawn

• 2 other identifiers: N1920-PI21RX001920-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.

Conditions

Brain Injuries, Traumatic

Keywords

Event-related potentials; Attention; Cognitive rehabilitation; Independent activities of daily living

Outcome Measures

Primary Outcomes (46)

• Timed Instrumental Activities of Daily Living (TIADL)

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Baseline TIADL Reaction Time assessed pretreatment

• Timed Instrumental Activities of Daily Living (TIADL)

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Change from Baseline in TIADL Reaction Time assessed at 8 weeks

• Timed Instrumental Activities of Daily Living (TIADL)

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)

• Timed Instrumental Activities of Daily Living (TIADL) - Accuracy

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Change from Baseline in TIADL Accuracy assessed at 4 weeks

• Timed Instrumental Activities of Daily Living (TIADL) - Accuracy

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Change from Baseline in TIADL Accuracy assessed at 8 weeks

• Timed Instrumental Activities of Daily Living (TIADL) - Accuracy

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score

  Assesses global outcome, including ability, adjustment and community participation indices.

  Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)

• Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Baseline (pretreatment) on TIADL - Reaction Time score

• Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score

  The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.

  Baseline (pretreatment) on TIADL - Accuracy score

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)

  Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.

  Baseline (pretreatment) MPAI-4 Adjustment score

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)

  Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.

  Baseline (pretreatment) MPAI-4 Participation score

• Attention Network Test (ANT) Alerting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Altering Reaction Time Score assessed at 4 weeks

• Attention Network Test (ANT) Alerting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Altering Reaction Time Score assessed at 8 weeks

• Attention Network Test (ANT) Alerting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)

• Attention Network Test (ANT) Orient Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline (pretreatment) Orienting Reaction Time score

• Attention Network Test (ANT) Orienting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks

• Attention Network Test (ANT) Orienting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks

• Attention Network Test (ANT) Orienting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)

• Attention Network Test (ANT) Executive-Control Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline (pretreatment) Executive-Control Reaction Time score

• Attention Network Test (ANT) Executive-Control Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks

• Attention Network Test (ANT) Executive-Control Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks

• Attention Network Test (ANT) Executive-Control Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)

• Attention Network Test (ANT) Alerting Reaction Time score

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline (pretreatment) Alerting Reaction Time score

• ANT ERP (N1) Alerting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment

• ANT ERP (N1) Alerting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks

• ANT ERP (N1) Alerting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks

• ANT ERP (N1) Alerting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)

• ANT ERP (N1) Orienting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment

• ANT ERP (N1) Orienting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks

• ANT ERP (N1) Orienting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks

• ANT ERP (N1) Orienting Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)

• ANT ERP (P3) Executive Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment

• ANT ERP (P3) Executive Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks

• ANT ERP (P3) Executive Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks

• ANT ERP (P3) Executive Amplitude

  The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.

  Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score

  Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.

  Baseline MPAI-4 Ability Score assessed pretreatment

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score

  Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.

  Baseline MPAI-4 Adjustment Score assessed pretreatment

• Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score

  Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.

  Baseline MPAI-4 Participation Score assessed pretreatment

Secondary Outcomes (8)

• Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)

  Change from Baseline in MAAS-LO Score assessed at 4 weeks

• Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)

  Change from Baseline in MAAS-LO Score assessed at 8 weeks

• Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)

  Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)

• Satisfaction with Life Scale (SWLS)

  Baseline SWLS Score assessed pretreatment

• Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)

  Baseline (pretreatment) on MAAS-LO

Other Outcomes (4)

• Ruff 2 & 7 Selective Attention Task (RSAT)

  Eligibility screening (Pretreatment)

• Reliable Digit Span (RDS)

  Eligibility screening (Pretreatment)

• Mental Health Screening Form 3rd edition (MHSF-III)

  Eligibility screening (Pretreatment)

Study Arms (2)

Direct-Metacognitive

EXPERIMENTAL

Direct attention training followed by metacognitive strategy training

Behavioral: Direct-attention training using web-based BrainHQ; Behavioral: Goal Management Training (GMT)

Metacognitive-Direct

EXPERIMENTAL

Metacognitive strategy training followed by direct-attention training

Behavioral: Direct-attention training using web-based BrainHQ; Behavioral: Goal Management Training (GMT)

Interventions

Direct-attention training using web-based BrainHQ BEHAVIORAL

BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."

Direct-Metacognitive; Metacognitive-Direct

Goal Management Training (GMT) BEHAVIORAL

A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.

Direct-Metacognitive; Metacognitive-Direct

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• OEF/OIF/OND Veterans with moderate or severe TBI as described by DOD/VA common definition.
• Self-report of attentional problems, confirmed with psychometric testing.
• Ruff 2 \& 7 selective attention task score \<= 1.5 standard deviations from demographically-matched norms.
• Able to participate in study at 12-60 months post injury without contraindications.
• Age 21-55 years.
• Willingness to be randomized and to participate in treatment procedures.
• Capacity to visit the laboratory for repeated treatment and testing sessions.
• Access to internet-enabled home computer.
• English as Native language.
• Adequate reading comprehension to allow completion of study-related questionnaires.
• Reliable digit span (RDS) score \> 7.

You may not qualify if:

• Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder).
• Current alcohol or drug use/dependence.
• Pre-existing severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
• Current suicidal or homicidal ideation.
• Reported involvement in current litigation.
• Reported history of pre-injury learning disability.
• Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation).
• Does not fully understand the nature of the study and requirements of participation.
• Does not understand task instructions.
• Validity testing score on RDS \<= 7.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• William M Perlstein, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 28, 2015
• Study Start: December 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)