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Brain Markers of Improvements in Cognitive Functioning

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VA Office of Research and Development

Status

Completed

Conditions

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

Treatments

Behavioral: State regulation skill training
Other: Treatment-as-usual

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03490110
N2240-P
16-12-00774 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

21 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 2 patient groups

State regulation skill training
Experimental group
Description:
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.
Treatment:
Behavioral: State regulation skill training
Treatment-as-usual
Active Comparator group
Description:
In this arm, participants receive clinical care as usual in VA and other clinics.
Treatment:
Other: Treatment-as-usual

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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