Brain Markers of Improvements in Cognitive Functioning

NCT03490110 | Completed Results

• 2 other identifiers: N2240-P16-12-00774
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury); Brain Injuries; Stress; Attention Deficit; Executive Dysfunction

Keywords

cognitive rehabilitation; EEG; TBI; brain networks; attention; memory; executive function

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 1, before intervention period (baseline)

• 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.

  Week 8, after the intervention period

Secondary Outcomes (3)

• Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)

  Week 8, after the intervention period

• Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)

  Week 1, before the intervention period

• Network Modularity From EEG

  Week 8, after the intervention period

Study Arms (2)

State regulation skill training

EXPERIMENTAL

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

Treatment-as-usual

ACTIVE COMPARATOR

In this arm, participants receive clinical care as usual in VA and other clinics.

Other: Treatment-as-usual

Interventions

State regulation skill training BEHAVIORAL

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).

State regulation skill training

Treatment-as-usual OTHER

Participants receive clinical care as usual over a matched time period.

Treatment-as-usual

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Northern California Health Care System: collaborator

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Anthony Chen
• Organization: Veterans Affairs

anthony.chen@va.gov

925-372-2530

Study Officials

• Anthony Chen, MD MA

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: training in brain state regulation compared to treatment-as-usual

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: April 6, 2018
• Study Start: October 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)