Brain Markers of Improvements in Cognitive Functioning

NCT ID: NCT03490110

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

State regulation skill training

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.

Group Type: EXPERIMENTAL

State regulation skill training

Intervention Type: 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).

Treatment-as-usual

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

Group Type: ACTIVE_COMPARATOR

Treatment-as-usual

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: BEHAVIORAL

Treatment-as-usual

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Northern California Health Care System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Chen, MD MA

Role: PRINCIPAL_INVESTIGATOR

VA Northern California Health Care System, Mather, CA

Locations

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-12-00774

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N2240-P

Identifier Type: -

Identifier Source: org_study_id