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Neuroplasticity in TBI and Schizophrenia (NVEST)

Primary Purpose

Schizophrenia, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, Traumatic Brain Injury, Neuroplasticity, EEG

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Veterans with a diagnosis of schizophrenia or a history of mild or moderate traumatic brain injury (TBI)
  • Veterans without a psychiatric diagnosis and no history of TBI (healthy control participants) will also be recruited
  • No other neurological or medical condition interfering with providing informed consent or valid assessment
  • No current depression based on the Structured Clinical Interview for DSM-5 (SCID-I) or depressive symptoms rated moderate or higher

    • a rating of 13 or higher on the Hamilton Depression Rating Scale
  • No DSM-V substance use disorder greater than mild severity in the past 3 months
  • No form of cognitive remediation in the 6 months prior to testing
  • An 8th grade reading level assessed with the Wide Range Achievement Test (WRAT)
  • Normal or corrected-to-normal vision and hearing

Exclusion Criteria:

Exclusion criteria for all patient participants include:

  • changes in medication dosage or type 3 months prior to testing
  • hospitalization for psychiatric health in the 3 months prior to testing
  • changes in housing status in the 6 months prior to testing

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

People with Schizophrenia

People with TBI

Healthy Controls

Arm Description

People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.

People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.

People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.

Outcomes

Primary Outcome Measures

Mismatch Negativity (MMN)
Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. MMN is measured while listening to a series of auditory tones, and is derived as the difference in responses to common stimuli minus rare stimuli (e.g., stimuli presented 90% of the time minus stimuli presented 10% of the time). A more negative value indicates stronger MMN.
Visual Long-Term Potentiation (LTP) Task
Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. This LTP task compares visual evoked potentials (VEPs) derived from the EEG before and after a period of extended visual stimulation.

Secondary Outcome Measures

Neurocognition
The MATRIC Consensus Cognitive Battery (MCCB) measures cognition in seven different domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) and provides a SINGLE summary t-score (age and gender corrected) of overall cognitive functioning.
Empathic Accuracy
Participants watch 9, short video clips of a person recounting a personal story. The participant must continuously rate how the person in the video is feeling while telling the story. The participant's ratings are then correlated with the ratings of the person who was in the video rating how they felt recounting their story. The average correlation for the 9 videos is the dependent variable, with higher positive correlations indicating higher empathic accuracy.
Community Integration
Community integration will be assessed by administering three separate scales (the Lubben Social Network Scale, the Role Functioning Scale, and the Community Integration Questionnaire). A single summary score (comprised of norming scores from each questionnaire and averaging over those normalized scores) is provided. A higher score indicates better community integration.
Ekman Facial Affect Identification
Participants view a series of 56 faces depicting one of seven different emotions (happy, sad, surprised, angry, afraid, disgusted, and neutral). The total number correctly identified faces is the outcome measure, with higher scores indicating better performance.

Full Information

First Posted
June 14, 2019
Last Updated
August 3, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03995368
Brief Title
Neuroplasticity in TBI and Schizophrenia
Acronym
NVEST
Official Title
New Applications of Neuroplasticity Biomarkers in Veterans With Traumatic Brain Injury or Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
April 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal will examine measures of neuroplasticity (the brain's ability to alter its function or structure in response to changes in the environment or novel experiences) in Veterans with schizophrenia or traumatic brain injury (TBI). Both conditions are associated with impaired cognition (for example, attention, memory, learning), which is in turn associated with poor community functioning and integration. However, the two disorders differ in their origins: schizophrenia is a neurodevelopmental disorder appearing usually in late adolescence while TBI is an acquired disorder as the result of an injury to the head. Understanding of the root causes of complex cognitive impairments associated with these disorders remains limited. Neuroplasticity is a fundamental brain process that underlies cognitive functioning and may give insight into the causes of cognitive dysfunction in TBI and schizophrenia. Neuroplasticity will be measured using electroencephalography (EEG) by placing small electrodes on the scalp that record the brain's electrical activity. Participants will listen to simple auditory tones and view simple visual patterns while their EEG is recorded. Additionally, participants will have measures of cognition and clinical interviews for diagnosis of a disorder as well as any current levels of symptoms.
Detailed Description
EEG recording: In this procedure, the participant's brain function will be recorded while listening to auditory tones or viewing simple visual stimuli. Participants will respond with a button press to specific tones or images. Participants will have all tasks clearly described to them and will practice each task prior to beginning the experiments. While performing these tasks, the brain's electrical activity (commonly referred to as "brain waves") will be recording using electroencephalography (EEG). Participant's will wear a cap that contains several electrodes (small, metal discs that are able to pick up electrical activity). A small amount of gel will be applied to the scalp underneath each electrode. These electrodes simply rest on the surface of the scalp and above and below the left eye. It takes approximately 15 minutes to place and prepare the electrodes. The entire recording session will last approximately 90 minutes (including setup). Before having EEG recorded it is important to wash the hair and scalp and not use conditioners or products in the hair as these may interfere with the electrical signal. The gel used is simply washed out of the hair with running water. During the auditory task, participants will listen to a series of tones while watching a silent movie. Participants do not need to pay attention to the tones. During the visual task, participants will view a series of images on a computer screen that consist of a checkerboard pattern. Periodically, they will be asked to respond with a button press if one of the images is different than the others. Interviews: There will be interviews conducted by trained staff that ask questions about participants' demographics (age, gender, education). A clinical interview will be given to all participants to determine if participants have either schizophrenia, a history of a traumatic brain injury, or have no psychiatric illness. All participants will be asked questions about how they are feeling. In addition, participants will answer questions about their family and friends and how they have been getting along with people in their lives. Behavioral testing: Participants will have measures of cognition assessed using various computer-based tasks and pen-and-pencil questionnaires. These tests assess aspects of cognition including memory, attention, language, and motor skills. Participants will also be asked to view a series of pictures of faces and identify the emotion depicted on the face. Finally, participants will be asked to view a series of short videos consisting of a person telling a personal story. Participants will continuously rate how they think that person in the video is feeling (happy, sad, angry, etc.) while telling their story. Additional Information: It may sometimes be necessary to contact a participant's physician to inquire about their medical history or diagnosis. Permission will be sought from participant's in order for contact to be made with their physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Traumatic Brain Injury
Keywords
Schizophrenia, Traumatic Brain Injury, Neuroplasticity, EEG

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will have the same tasks delivered in the same manner.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
People with Schizophrenia
Arm Type
Experimental
Arm Description
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime.
Arm Title
People with TBI
Arm Type
Experimental
Arm Description
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI.
Intervention Type
Other
Intervention Name(s)
Electroencephalography
Other Intervention Name(s)
EEG
Intervention Description
The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.
Primary Outcome Measure Information:
Title
Mismatch Negativity (MMN)
Description
Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. MMN is measured while listening to a series of auditory tones, and is derived as the difference in responses to common stimuli minus rare stimuli (e.g., stimuli presented 90% of the time minus stimuli presented 10% of the time). A more negative value indicates stronger MMN.
Time Frame
1 Day
Title
Visual Long-Term Potentiation (LTP) Task
Description
Electroencephalography (EEG) measures the brain's activity while viewing simple visual stimuli or listening to simple auditory tones. This LTP task compares visual evoked potentials (VEPs) derived from the EEG before and after a period of extended visual stimulation.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Neurocognition
Description
The MATRIC Consensus Cognitive Battery (MCCB) measures cognition in seven different domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) and provides a SINGLE summary t-score (age and gender corrected) of overall cognitive functioning.
Time Frame
1 Day
Title
Empathic Accuracy
Description
Participants watch 9, short video clips of a person recounting a personal story. The participant must continuously rate how the person in the video is feeling while telling the story. The participant's ratings are then correlated with the ratings of the person who was in the video rating how they felt recounting their story. The average correlation for the 9 videos is the dependent variable, with higher positive correlations indicating higher empathic accuracy.
Time Frame
1 Day
Title
Community Integration
Description
Community integration will be assessed by administering three separate scales (the Lubben Social Network Scale, the Role Functioning Scale, and the Community Integration Questionnaire). A single summary score (comprised of norming scores from each questionnaire and averaging over those normalized scores) is provided. A higher score indicates better community integration.
Time Frame
1 Day
Title
Ekman Facial Affect Identification
Description
Participants view a series of 56 faces depicting one of seven different emotions (happy, sad, surprised, angry, afraid, disgusted, and neutral). The total number correctly identified faces is the outcome measure, with higher scores indicating better performance.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veterans with a diagnosis of schizophrenia or a history of mild or moderate traumatic brain injury (TBI) Veterans without a psychiatric diagnosis and no history of TBI (healthy control participants) will also be recruited No other neurological or medical condition interfering with providing informed consent or valid assessment No current depression based on the Structured Clinical Interview for DSM-5 (SCID-I) or depressive symptoms rated moderate or higher a rating of 13 or higher on the Hamilton Depression Rating Scale No DSM-V substance use disorder greater than mild severity in the past 3 months No form of cognitive remediation in the 6 months prior to testing An 8th grade reading level assessed with the Wide Range Achievement Test (WRAT) Normal or corrected-to-normal vision and hearing Exclusion Criteria: Exclusion criteria for all patient participants include: changes in medication dosage or type 3 months prior to testing hospitalization for psychiatric health in the 3 months prior to testing changes in housing status in the 6 months prior to testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Wynn, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://greenlab.dgsom.ucla.edu
Description
The Green Lab

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Neuroplasticity in TBI and Schizophrenia

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