N/A
N=93
Neuroplasticity in TBI and Schizophrenia
Schizophrenia · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03995368 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Mismatch Negativity (MMN) Amplitudes in Microvolts — -0.59; -1.19; -0.41; -0.65 microvolts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electroencephalography (Other)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mismatch Negativity (MMN) Amplitudes in Microvolts |
-0.59; -1.19; -0.41; -0.65; -1.87; -1.75 | — |
| PRIMARY Visual Long-Term Potentiation (LTP) Task |
0.295; 0.201; 0.274; 1.215; 1.145; 1.149 | — |
| SECONDARY Neurocognition |
35.13; 45.32; 46.29 | — |
| SECONDARY Empathic Accuracy |
— | — |
| SECONDARY Community Integration |
5.88; 6.05; 6.67; 7.24; 8.45; 8.96 | — |
| SECONDARY Ekman Facial Affect Identification |
42.4; 46.4; 44.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03995368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.