Remediation of Auditory Recognition in Schizophrenia With tDCS

Study Overview
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Brief Summary
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The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.

Detailed Description
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This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.

Official Title
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Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Device: Active Transcranial direct current stimulation (tDCS)
* Device: Sham Transcranial direct current stimulation (tDCS)
* Behavioral: Auditory Remediation
* Behavioral: Control computer activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 Primary diagnosis of Schizophrenia or schizoaffective disorder English fluency Willing/capable to provide informed consent Auditory tone matching deficits Receiving stable doses of antipsychotic medication(s) for at least 2 weeks IQ>75 Exclusion Criteria: Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders. Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine) Pregnancy or breastfeeding Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auditory remediation with active tDCS<br>Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week | Device: Active Transcranial direct current stimulation (tDCS)<br>* Active tDCS, where an extremely weak electric current passes through the brain<br>Behavioral: Auditory Remediation<br>* Computer program designed to improve discrimination between sounds<br>|
| Experimental: Auditory remediation with sham tDCS<br>Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week | Device: Sham Transcranial direct current stimulation (tDCS)<br>* Sham (inactive or placebo) tDCS<br>Behavioral: Auditory Remediation<br>* Computer program designed to improve discrimination between sounds<br>|
| Sham Comparator: Control (computer games with sham tDCS)<br>Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week | Device: Sham Transcranial direct current stimulation (tDCS)<br>* Sham (inactive or placebo) tDCS<br>Behavioral: Control computer activities<br>* Computer program (e.g. games), which are not designed to improve discrimination between sounds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory Tone Matching Task | Ability to match tones following brief delay | Change in performance from Baseline at completion of training (week 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory Emotion Recognition (AER) Task | Ability to detect emotion based on tone of voice | Change in performance from Baseline at completion of training (week 16) | 
| ER-40 | Penn Emotion Recognition Test-40 Faces Version | Change in performance from Baseline at completion of training (week 16) | 
| The Awareness of Social Inference Test (TASIT) | The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better. | Change in performance from Baseline at completion of training (week 16) | 
| Auditory Mismatch Negativity (MMN) | Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG) | Change in performance from Baseline at completion of training (week 16) |