Clinical trial NCT03490110: Brain Markers of Improvements in Cognitive Functioning
Official title: EEG Markers of Training-Induced Improvements in Cognitive Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Brain Injuries
Stress
Attention Deficit
Executive Dysfunction
Keywords: cognitive rehabilitation
EEG
TBI
brain networks
attention
memory
executive function
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Northern California Health Care System
First posted: 2018-04-06
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: training in brain state regulation compared to treatment-as-usual
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
timeFrame: Week 1, before intervention period (baseline)
measure: Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
timeFrame: Week 8, after the intervention period
Secondary outcomes:
measure: Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)
timeFrame: Week 8, after the intervention period
measure: Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)
timeFrame: Week 1, before the intervention period
measure: Network Modularity From EEG
timeFrame: Week 8, after the intervention period
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Anthony Chen, MD MA
role: PRINCIPAL_INVESTIGATOR
References: