Clinical trial NCT02589509: Cognitive Rehabilitation and Brain Activity of Attention Control in TBI
Official title: Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Injuries, Traumatic
Keywords: Event-related potentials
Attention
Cognitive rehabilitation
Independent activities of daily living
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Attention impairment is ubiquitous in TBI survivors. This is a devastating impairment because attention is the backbone of cognitive systems. Attention is requisite for other cognitive processes that are vital to everyday functioning such as memory, problem solving, language skills, and the cognitive control of behavior. Studies of attention training have shown improved attention on laboratory measures, but limited translation to real-world tasks. Notably, these previously-tested rehabilitation approaches have not included training in the very cognitive processes needed for translation of training to everyday tasks which include internal verbalization and self-monitoring, also called metacognitive strategies. One training method for metacognitive strategies has shown promise, but is lacking in basic attention training. Rehabilitation specialists have recently argued for a rehabilitation approach wherein both basic foundational attention and metacognitive strategies should be synergistically combined. Consequently, the investigators will test an innovative combination of direct-attention training and metacognitive training for which the other compensates disadvantages of each. Because of the promise of each type of training separately, and the potential additive effects of the combination, it is critical to test this combined attention and metacognitive training in Veteran survivors of chronic moderate-to-severe traumatic brain injury (TBI). The investigators will address the following two specific aims: the investigators propose to conduct a pilot study to examine cognitive rehabilitation therapy (CRT) effects in a group of Veterans with chronic moderate to severe TBI (m/sTBI), focused on remediating attention-control impairments using both direct-attention and metacognitive-strategy training approaches in a AB/BA crossover design with 1-month follow-up to address the following two specific aims: 1) Test treatment response to combined direct-attention and metacognitive-strategy training in Veterans with chronic m/sTBI; and 2) identify mechanisms and biomarkers of rehabilitation-related neuroplasticity. Under the first aim the investigators will test for effects of combined direct-attention and metacognitive-strategy training on measures of complex functional activities and neurocognitive tests of attention-control functions. Under the second aim, the investigators will test effects of the their CRT approach on behavioral and brain activity while participants perform a well-validated attentional task that probes the function of three dissociable attentional systems. The approach is innovative because it combines a theoretically motivated and novel approach to address a significant source of disability in Veteran survivors of TBI. The proposed research is significant because findings will form the foundation for a larger-scale trial to enable us to determine the durability of gains and the functional impact of treatment on Veteran's real world activities and to more positively shape healthcare for our Veterans who are suffering from TBI. Outcome measures will include standardized tests of neurocognitive functioning such as attention and other cognitive skills, measures of self care, ability to live independently, social role participation, life satisfaction, TBI-related quality of life, mood/anxiety, and attention-related scalp-recorded brain event-related potentials (ERPs, derived from electroencephalography).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Timed Instrumental Activities of Daily Living (TIADL)
timeFrame: Baseline TIADL Reaction Time assessed pretreatment
measure: Timed Instrumental Activities of Daily Living (TIADL)
timeFrame: Change from Baseline in TIADL Reaction Time assessed at 8 weeks
measure: Timed Instrumental Activities of Daily Living (TIADL)
timeFrame: Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)
measure: Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
timeFrame: Change from Baseline in TIADL Accuracy assessed at 4 weeks
measure: Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
timeFrame: Change from Baseline in TIADL Accuracy assessed at 8 weeks
measure: Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
timeFrame: Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
timeFrame: Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
timeFrame: Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
timeFrame: Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
timeFrame: Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
timeFrame: Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
timeFrame: Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
timeFrame: Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
timeFrame: Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
timeFrame: Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)
measure: Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score
timeFrame: Baseline (pretreatment) on TIADL - Reaction Time score
measure: Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score
timeFrame: Baseline (pretreatment) on TIADL - Accuracy score
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
timeFrame: Baseline (pretreatment) MPAI-4 Adjustment score
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
timeFrame: Baseline (pretreatment) MPAI-4 Participation score
measure: Attention Network Test (ANT) Alerting Reaction Time score
timeFrame: Change from Baseline in Altering Reaction Time Score assessed at 4 weeks
measure: Attention Network Test (ANT) Alerting Reaction Time score
timeFrame: Change from Baseline in Altering Reaction Time Score assessed at 8 weeks
measure: Attention Network Test (ANT) Alerting Reaction Time score
timeFrame: Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)
measure: Attention Network Test (ANT) Orient Reaction Time score
timeFrame: Baseline (pretreatment) Orienting Reaction Time score
measure: Attention Network Test (ANT) Orienting Reaction Time score
timeFrame: Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks
measure: Attention Network Test (ANT) Orienting Reaction Time score
timeFrame: Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks
measure: Attention Network Test (ANT) Orienting Reaction Time score
timeFrame: Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)
measure: Attention Network Test (ANT) Executive-Control Reaction Time score
timeFrame: Baseline (pretreatment) Executive-Control Reaction Time score
measure: Attention Network Test (ANT) Executive-Control Reaction Time score
timeFrame: Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks
measure: Attention Network Test (ANT) Executive-Control Reaction Time score
timeFrame: Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks
measure: Attention Network Test (ANT) Executive-Control Reaction Time score
timeFrame: Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)
measure: Attention Network Test (ANT) Alerting Reaction Time score
timeFrame: Baseline (pretreatment) Alerting Reaction Time score
measure: ANT ERP (N1) Alerting Amplitude
timeFrame: Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment
measure: ANT ERP (N1) Alerting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks
measure: ANT ERP (N1) Alerting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks
measure: ANT ERP (N1) Alerting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)
measure: ANT ERP (N1) Orienting Amplitude
timeFrame: Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment
measure: ANT ERP (N1) Orienting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks
measure: ANT ERP (N1) Orienting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks
measure: ANT ERP (N1) Orienting Amplitude
timeFrame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)
measure: ANT ERP (P3) Executive Amplitude
timeFrame: Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment
measure: ANT ERP (P3) Executive Amplitude
timeFrame: Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks
measure: ANT ERP (P3) Executive Amplitude
timeFrame: Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks
measure: ANT ERP (P3) Executive Amplitude
timeFrame: Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
timeFrame: Baseline MPAI-4 Ability Score assessed pretreatment
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
timeFrame: Baseline MPAI-4 Adjustment Score assessed pretreatment
measure: Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
timeFrame: Baseline MPAI-4 Participation Score assessed pretreatment
Secondary outcomes:
measure: Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
timeFrame: Change from Baseline in MAAS-LO Score assessed at 4 weeks
measure: Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
timeFrame: Change from Baseline in MAAS-LO Score assessed at 8 weeks
measure: Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
timeFrame: Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Baseline SWLS Score assessed pretreatment
measure: Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
timeFrame: Baseline (pretreatment) on MAAS-LO
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from Baseline in SWLS Score assessed at 4 weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from Baseline in SWLS Score assessed at 8 weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment)
Other outcomes:
measure: Ruff 2 & 7 Selective Attention Task (RSAT)
timeFrame: Eligibility screening (Pretreatment)
measure: Reliable Digit Span (RDS)
timeFrame: Eligibility screening (Pretreatment)
measure: Mental Health Screening Form 3rd edition (MHSF-III)
timeFrame: Eligibility screening (Pretreatment)
measure: Wide Range Achievement Test, 4th edition (WRAT-4; word-reading subtest)
timeFrame: Group matching (Pretreatment)
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: William M Perlstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: