Attention Deficit, Brain Injuries, Executive Dysfunction, Stress, TBI (Traumatic Brain Injury)
Conditions
Keywords
cognitive rehabilitation, EEG, TBI, brain networks, attention, memory, executive function
Brief summary
Some of the most common, persistent, and disabling consequences of traumatic brain injury affect an individual's ability to achieve personal goals. Interventions that strengthen abilities such as being able to concentrate, remember, stay calm and overcome challenges, could have far reaching benefits for Veterans. One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform care. This pilot project will test the clinical behavioral effects of a cognitive skill training intervention and explore to what extent changes in markers of the brain's electrical activity (using the non-invasive technique of electroencephalograms, EEG) can explain differences in responses to skill training.
Detailed description
Detailed Description: Traumatic brain injuries (TBI) can impair cognitive functioning long after the initial trauma. Some of the most common, persistent, and disabling consequences of traumatic brain injury are deficits in higher order cognitive functions that direct more basic processes based on an individual's goals. Symptoms such as distractibility and difficulty holding goal-relevant information in memory can affect achievement of personal and professional goals. These cognitive problems can be exacerbated by post-traumatic stress (PTS) symptoms, commonly observed in the Veteran population. Interventions that strengthen goal-directed regulation of cognitive-emotion states could have far reaching benefits for Veterans. One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform patient care. Investigators have developed a system for training neurocognitive skills that can be used in rehabilitation neuroscience studies to elucidate the neural bases of improvements in cognitive functioning. The training system is designed to help patients improve goal-directed brain state regulation, and preliminary work has investigated brain network parameters that may predict response to training. Electroencephalography (EEG) potentially provides easily accessible markers for the neural bases of improvements with training. Objectives in this pilot study are to investigate the potential of EEG markers to: (1) explain differential responses to attention regulation training; and (2) predict responses to training.
Interventions
BEHAVIORALState regulation skill training
Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \ 4.5 hours per week).
OTHERTreatment-as-usual
Participants receive clinical care as usual over a matched time period.
Sponsors
VA Northern California Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
training in brain state regulation compared to treatment-as-usual
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Veterans * History of TBI (as defined by the American Congress of Rehabilitation Medicine and VA, with reported plausible mechanism of head injury, loss of consciousness with some period of posttraumatic alteration in cognition), in the chronic, stable phase of recovery (\>6 months from injury) * On stable psychoactive medications (\> 30 days) * Able and willing to participate in EEG, training and, assessments
Exclusion criteria
* Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate with the training tasks * Severe cognitive dysfunction * History of neurodevelopmental abnormalities * Ongoing illicit drug or alcohol abuse * Schizophrenia * Bipolar disorder * History of other neurological disorders * Current medical illnesses that may alter mental status or disrupt participation in the study * Active psychotropic medication changes * There will be no restriction in regard to gender, race, and socioeconomic status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery | Week 1, before intervention period (baseline) | The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; & Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | Week 8, after the intervention period | Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data as change from before to after the intervention period. |
| Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | Week 1, before the intervention period | Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data prior to the intervention period. |
| Network Modularity From EEG | Week 8, after the intervention period | EEG will be collected during a focused rest condition. Network modularity will be estimated from a matrix of connections between electrodes based on phase coherence, a unit-less measure of correlation between phase angles of EEG signals in the theta (4-8 Hz) frequency range. The modularity metric reflects the strength of modular network organization by summing the difference between the fraction of within-module connections to the total fraction of connections across modules, thus ranging from 0 (random) to 1 (completely modular). Change in network modularity will be analyzed for this data as change from before to after the intervention period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| State Regulation Skill Training This arm utilizes a training system designed to strengthen goal-directed cognitive-emotional state regulation skills. The emphasis is on practice and active application of skills across a range of challenge contexts. Digital scenarios provide experiential learning opportunities, allowing Veterans to apply skills to tackle challenges that are calibrated to maximize learning. Coaches guide learning for successful application of skills to challenges in personal life.
State regulation skill training: Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \
4.5 hours per week). | 9 |
| Treatment-as-usual In this arm, participants receive clinical care as usual in VA and other clinics.
Treatment-as-usual: Participants receive clinical care as usual over a matched time period. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | State Regulation Skill Training | Treatment-as-usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 40.4 years STANDARD_DEVIATION 9 | 38.00 years STANDARD_DEVIATION 9.61 | 39.29 years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; & Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively.
Time frame: Week 1, before intervention period (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| State Regulation Skill Training | Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery | 0.18 units on a scale | Standard Deviation 0.79 |
| Treatment-as-usual | Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery | -0.06 units on a scale | Standard Deviation 0.72 |
Primary
Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; & Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively. Change will be analyzed for this data as change from before to after the intervention period.
Time frame: Week 8, after the intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| State Regulation Skill Training | Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery | 0.49 units on a scale | Standard Deviation 0.75 |
| Treatment-as-usual | Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery | -0.13 units on a scale | Standard Deviation 0.45 |
Secondary
Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)
Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data as change from before to after the intervention period.
Time frame: Week 8, after the intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| State Regulation Skill Training | Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - Pz | 1.55 uV | Standard Deviation 1.88 |
| State Regulation Skill Training | Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - CPz | 2.27 uV | Standard Deviation 2.61 |
| Treatment-as-usual | Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - Pz | -0.42 uV | Standard Deviation 1.58 |
| Treatment-as-usual | Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - CPz | 0.32 uV | Standard Deviation 1.17 |
Secondary
Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)
Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data prior to the intervention period.
Time frame: Week 1, before the intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| State Regulation Skill Training | Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - Pz | 0.56 uV | Standard Deviation 1.06 |
| State Regulation Skill Training | Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - CPz | 1.41 uV | Standard Deviation 2.3 |
| Treatment-as-usual | Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - Pz | -0.07 uV | Standard Deviation 1.37 |
| Treatment-as-usual | Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) | EEG Electrode - CPz | 0.60 uV | Standard Deviation 0.99 |
Secondary
Network Modularity From EEG
EEG will be collected during a focused rest condition. Network modularity will be estimated from a matrix of connections between electrodes based on phase coherence, a unit-less measure of correlation between phase angles of EEG signals in the theta (4-8 Hz) frequency range. The modularity metric reflects the strength of modular network organization by summing the difference between the fraction of within-module connections to the total fraction of connections across modules, thus ranging from 0 (random) to 1 (completely modular). Change in network modularity will be analyzed for this data as change from before to after the intervention period.
Time frame: Week 8, after the intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| State Regulation Skill Training | Network Modularity From EEG | 0.001 units on a scale | Standard Deviation 0.018 |
| Treatment-as-usual | Network Modularity From EEG | -0.002 units on a scale | Standard Deviation 0.013 |