Trial Outcomes & Findings for Neuroplasticity in TBI and Schizophrenia (NCT NCT03995368)

NCT ID: NCT03995368

Last Updated: 2024-09-19

Results Overview

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, a more positive value indicates a stronger Repetition Positivity (RP) to the Standard stimuli, and a more negative value indicates a stronger Deviant Negativity (DN) to the Deviant stimuli. The investigators examined the deviant negativity, repetition positivity, and the MMN (which is defined as the difference between the standard-deviant), at three different standard tone repetition sequences (2, 6, or 36). In each case, the RP, DN, and MMN get stronger (i.e., larger amplitude) as the number of standard repetitions (2, 6, 36) increase.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

1 Day

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure
People With Schizophrenia
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Overall Study
STARTED
28
34
31
Overall Study
COMPLETED
26
23
26
Overall Study
NOT COMPLETED
2
11
5

Reasons for withdrawal

Reasons for withdrawal
Measure
People With Schizophrenia
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Overall Study
Lost to Follow-up
1
4
1
Overall Study
Did not meet inclusion criteria
1
6
3
Overall Study
Withdrawal by Subject
0
1
1

Baseline Characteristics

Neuroplasticity in TBI and Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
People With Schizophrenia
n=26 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=23 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=26 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
52.5 years
STANDARD_DEVIATION 9.8 • n=99 Participants
42.9 years
STANDARD_DEVIATION 12.9 • n=107 Participants
49.1 years
STANDARD_DEVIATION 12.9 • n=206 Participants
48.4 years
STANDARD_DEVIATION 12.4 • n=7 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
7 Participants
n=7 Participants
Sex: Female, Male
Male
20 Participants
n=99 Participants
23 Participants
n=107 Participants
25 Participants
n=206 Participants
68 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=99 Participants
6 Participants
n=107 Participants
7 Participants
n=206 Participants
19 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=99 Participants
17 Participants
n=107 Participants
19 Participants
n=206 Participants
56 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
3 Participants
n=7 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=99 Participants
7 Participants
n=107 Participants
15 Participants
n=206 Participants
36 Participants
n=7 Participants
Race (NIH/OMB)
White
12 Participants
n=99 Participants
11 Participants
n=107 Participants
8 Participants
n=206 Participants
31 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
3 Participants
n=107 Participants
1 Participants
n=206 Participants
4 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Region of Enrollment
United States
26 Participants
n=99 Participants
23 Participants
n=107 Participants
26 Participants
n=206 Participants
75 Participants
n=7 Participants

PRIMARY outcome

Timeframe: 1 Day

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, a more positive value indicates a stronger Repetition Positivity (RP) to the Standard stimuli, and a more negative value indicates a stronger Deviant Negativity (DN) to the Deviant stimuli. The investigators examined the deviant negativity, repetition positivity, and the MMN (which is defined as the difference between the standard-deviant), at three different standard tone repetition sequences (2, 6, or 36). In each case, the RP, DN, and MMN get stronger (i.e., larger amplitude) as the number of standard repetitions (2, 6, 36) increase.

Outcome measures

Outcome measures
Measure
People With Schizophrenia
n=25 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=22 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=25 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Mismatch Negativity (MMN) Amplitudes in Microvolts
Deviant36
-0.98 microvolts
Standard Deviation 1.69
-3.05 microvolts
Standard Deviation 1.90
-2.55 microvolts
Standard Deviation 2.19
Mismatch Negativity (MMN) Amplitudes in Microvolts
MMN2
-0.59 microvolts
Standard Deviation 2.38
-1.19 microvolts
Standard Deviation 1.88
-0.41 microvolts
Standard Deviation 1.89
Mismatch Negativity (MMN) Amplitudes in Microvolts
MMN6
-0.65 microvolts
Standard Deviation 2.01
-1.87 microvolts
Standard Deviation 1.98
-1.75 microvolts
Standard Deviation 2.11
Mismatch Negativity (MMN) Amplitudes in Microvolts
MMN36
-1.14 microvolts
Standard Deviation 1.92
-3.13 microvolts
Standard Deviation 2.42
-2.90 microvolts
Standard Deviation 2.86
Mismatch Negativity (MMN) Amplitudes in Microvolts
Standard2
0.04 microvolts
Standard Deviation 1.53
-0.46 microvolts
Standard Deviation 1.43
-0.91 microvolts
Standard Deviation 1.27
Mismatch Negativity (MMN) Amplitudes in Microvolts
Standard6
-0.15 microvolts
Standard Deviation 1.39
-0.40 microvolts
Standard Deviation 1.23
0.34 microvolts
Standard Deviation 1.15
Mismatch Negativity (MMN) Amplitudes in Microvolts
Standard36
0.16 microvolts
Standard Deviation 1.02
0.08 microvolts
Standard Deviation 1.34
0.35 microvolts
Standard Deviation 1.44
Mismatch Negativity (MMN) Amplitudes in Microvolts
Deviant2
-0.54 microvolts
Standard Deviation 1.82
-1.66 microvolts
Standard Deviation 1.36
-1.32 microvolts
Standard Deviation 1.73
Mismatch Negativity (MMN) Amplitudes in Microvolts
Deviant6
-0.80 microvolts
Standard Deviation 1.44
-2.26 microvolts
Standard Deviation 1.60
-1.40 microvolts
Standard Deviation 2.00

PRIMARY outcome

Timeframe: 1 Day

This LTP task compares visual evoked potentials (VEPs) derived from the EEG before and after a period of extended visual stimulation (tetanization). We measured VEP amplitudes to two different checkerboard patterns before (pre-) and at three time points after (post-) a 10-minute prolonged tetanization checkerboard. VEPs were measured to tetanized (i.e., the same stimuli used in the 10-minute tetanization) or not tetanized (a different checkerboard pattern than the one used in tetanization) stimuli, prior to baseline (pre-), and at 5- (Post 1), 10- (Post 2), and 15- (Post 3) minutes after tetanization. This resulted in 4 VEP measurements for each tetanized and non-tetanized checkerboard. We focused on relative changes from baseline for evidence of plasticity and input specificity (i.e., tetanized vs. non-tetanized stimuli) at each of the 3 post-tetanization time points.

Outcome measures

Outcome measures
Measure
People With Schizophrenia
n=24 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=22 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=23 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Visual Long-Term Potentiation (LTP) Task
Post-tetanization 3
0.475 microvolt
Standard Deviation 1.803
0.226 microvolt
Standard Deviation 1.722
0.540 microvolt
Standard Deviation 1.508
Visual Long-Term Potentiation (LTP) Task
Post-NonTetanized 2
0.465 microvolt
Standard Deviation 0.951
0.364 microvolt
Standard Deviation 1.515
0.334 microvolt
Standard Deviation 1.408
Visual Long-Term Potentiation (LTP) Task
Post-NonTetanized 3
0.325 microvolt
Standard Deviation 0.857
0.705 microvolt
Standard Deviation 1.303
0.142 microvolt
Standard Deviation 1.054
Visual Long-Term Potentiation (LTP) Task
Pre-tetanization
0.295 microvolt
Standard Deviation 1.758
0.201 microvolt
Standard Deviation 1.530
0.274 microvolt
Standard Deviation 1.554
Visual Long-Term Potentiation (LTP) Task
Post-tetanization 1
1.215 microvolt
Standard Deviation 1.601
1.145 microvolt
Standard Deviation 1.217
1.149 microvolt
Standard Deviation 1.316
Visual Long-Term Potentiation (LTP) Task
Post-tetanization 2
0.677 microvolt
Standard Deviation 1.489
0.360 microvolt
Standard Deviation 1.563
0.662 microvolt
Standard Deviation 1.319
Visual Long-Term Potentiation (LTP) Task
Pre-NonTetanized
0.207 microvolt
Standard Deviation 0.664
0.155 microvolt
Standard Deviation 1.378
0.049 microvolt
Standard Deviation 1.203
Visual Long-Term Potentiation (LTP) Task
Post-NonTetanized 1
0.557 microvolt
Standard Deviation 0.978
0.197 microvolt
Standard Deviation 1.217
0.508 microvolt
Standard Deviation 1.271

SECONDARY outcome

Timeframe: 1 Day

The MATRICS 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. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.

Outcome measures

Outcome measures
Measure
People With Schizophrenia
n=24 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=22 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=24 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Neurocognition
35.13 t-score
Standard Deviation 15.18
45.32 t-score
Standard Deviation 11.34
46.29 t-score
Standard Deviation 12.42

SECONDARY outcome

Timeframe: 1 Day

Population: We are unable to analyze the data due to an error in the scoring script that is not fixable.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: A higher score indicates better functioning. CIQ-home ranges from 0-10, CIQ-social ranges from 0-12, and CIQ-activities ranges from 0-17.

Community integration will be assessed by administering the Community Integration Questionnaire, which has 3 sub-scores (home, social, and activities). A higher score indicates better community integration.

Outcome measures

Outcome measures
Measure
People With Schizophrenia
n=25 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=22 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=24 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Community Integration
CIQ-home
5.88 score on a scale
Standard Error 3.046
6.05 score on a scale
Standard Error 2.870
6.67 score on a scale
Standard Error 2.461
Community Integration
CIQ-social
7.24 score on a scale
Standard Error 2.332
8.45 score on a scale
Standard Error 2.385
8.96 score on a scale
Standard Error 2.116
Community Integration
CIQ-activities
3.00 score on a scale
Standard Error 1.581
4.36 score on a scale
Standard Error 1.56
3.96 score on a scale
Standard Error 1.574

SECONDARY outcome

Timeframe: 1 Day

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. Scores range from 0-56, with 56 indicating 100% accurate facial affect identification.

Outcome measures

Outcome measures
Measure
People With Schizophrenia
n=25 Participants
People who have been diagnosed with schizophrenia and meet the investigators' research criteria for symptoms indicative of schizophrenia within their lifetime. Electroencephalography: 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.
People With TBI
n=22 Participants
People who have been diagnosed with a mild or moderate traumatic brain injury (TBI) and meet research criteria indicative of TBI within their lifetime. Electroencephalography: 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.
Healthy Controls
n=25 Participants
People without a history of psychiatric illness or TBI and who do not meet research criteria for a psychiatric illness or TBI. Electroencephalography: 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.
Ekman Facial Affect Identification
42.4 score on a scale (total out of 56)
Standard Deviation 7.1
46.4 score on a scale (total out of 56)
Standard Deviation 5.9
44.6 score on a scale (total out of 56)
Standard Deviation 5.7

Adverse Events

People With Schizophrenia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

People With TBI

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan K. Wynn

VA Greater Los Angeles Healthcare System

Phone: 3104783711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place