Stress Clinical Trial - Brain Markers of Improvements in Cognitive

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03490110
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2017
Completion date	June 1, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Brain Markers of Improvements in Cognitive Functioning

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms