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Brain Markers of Improvements in Cognitive Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490110
Recruitment Status : Completed
First Posted : April 6, 2018
Results First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Brain Injuries Stress Attention Deficit Executive Dysfunction Behavioral: State regulation skill training Other: Treatment-as-usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: training in brain state regulation compared to treatment-as-usual
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EEG Markers of Training-Induced Improvements in Cognitive Functioning
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : June 1, 2019

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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).

Active Comparator: Treatment-as-usual
In this arm, participants receive clinical care as usual in VA and other clinics.
Other: Treatment-as-usual
Participants receive clinical care as usual over a matched time period.




Primary Outcome Measures :
  1. Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery [ Time Frame: 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.


  2. Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery [ Time Frame: Week 8, after the intervention period ]

    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.



Secondary Outcome Measures :
  1. Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) [ Time Frame: 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.

  2. Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV) [ Time Frame: 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.

  3. Network Modularity From EEG [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490110


Locations
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United States, California
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655
Sponsors and Collaborators
VA Office of Research and Development
VA Northern California Health Care System
Investigators
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Principal Investigator: Anthony Chen, MD MA VA Northern California Health Care System, Mather, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03490110    
Other Study ID Numbers: N2240-P
16-12-00774 ( Other Grant/Funding Number: VA Northern California Health Care System )
First Posted: April 6, 2018    Key Record Dates
Results First Posted: March 23, 2020
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
cognitive rehabilitation
EEG
TBI
brain networks
attention
memory
executive function
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System