Have you or your loved ones been diagnosed with attention deficit?

You may be eligible to participate in a attention deficit clinical trial.

Have you or your loved ones been diagnosed with attention deficit? You may be eligible to participate in a attention deficit clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Attention Deficit Clinical Trial in Sacramento CA

NCT03490110 | Interventional

Have you or your loved ones been diagnosed with attention deficit?

You may be eligible to participate in a attention deficit clinical trial.

Have you or your loved ones been diagnosed with attention deficit? You may be eligible to participate in a attention deficit clinical trial.

Completed

Male & Female

21 - 55

Years old

This study has recruited 18 Participants

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.

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Details for the study

Brief Title

Brain Markers of Improvements in Cognitive Functioning

Official Title

EEG Markers of Training-Induced Improvements in Cognitive Functioning

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.

Treatments and/or Procedures

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).

Treatment as usual

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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.

Week 8, after the intervention period

Primary

Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery

Week 1, before intervention period (baseline)

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.

Week 8, after the intervention period

Secondary

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

Week 1, before the intervention period

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.

Week 8, after the intervention period

Study 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