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| Name | Class |
|---|---|
| Nathan Kline Institute for Psychiatric Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory remediation with active tDCS | Experimental | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
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| Auditory remediation with sham tDCS | Experimental | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
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| Control (computer games with sham tDCS) | Sham Comparator | Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial direct current stimulation (tDCS) | Device | Active tDCS, where an extremely weak electric current passes through the brain |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Javitt, MD, PhD | NY State Psychiatric Institute, Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33539561 | Derived | Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2. |
| Label | URL |
|---|---|
| New York State Psychiatric Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auditory Remediation With Active tDCS | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2016 |
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| Sham Transcranial direct current stimulation (tDCS) | Device | Sham (inactive or placebo) tDCS |
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| Auditory Remediation | Behavioral | Computer program designed to improve discrimination between sounds |
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| Control computer activities | Behavioral | Computer program (e.g. games), which are not designed to improve discrimination between sounds |
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| 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) |
| Department of Psychiatry, Columbia University Medical Center | View source |
| FG001 | Auditory Remediation With Sham tDCS | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Auditory Remediation With Active tDCS | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds |
| BG001 | Auditory Remediation With Sham tDCS | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Tone matching (i.e. ability to match tones following brief delay) | Mean | Standard Deviation | percent correct |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Auditory Tone Matching Task | Ability to match tones following brief delay | completers | Posted | Mean | Standard Deviation | %correct, different trials | Change in performance from Baseline at completion of training (week 16) |
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| Secondary | Auditory Emotion Recognition (AER) Task | Ability to detect emotion based on tone of voice | Posted | Mean | Standard Deviation | %correct | Change in performance from Baseline at completion of training (week 16) |
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| Secondary | ER-40 | Penn Emotion Recognition Test-40 Faces Version | Posted | Mean | Standard Deviation | percent correct | Change in performance from Baseline at completion of training (week 16) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change in performance from Baseline at completion of training (week 16) |
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| Secondary | Auditory Mismatch Negativity (MMN) | Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG) | Subjects who completed post-testing and had usable data | Posted | Mean | Standard Deviation | microvolt | Change in performance from Baseline at completion of training (week 16) |
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16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auditory Remediation With Active tDCS | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds | 0 | 2 | 0 | 2 | 1 | 2 |
| EG001 | Auditory Remediation With Sham tDCS | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds | 0 | 3 | 0 | 3 | 0 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sedation | Nervous system disorders | Systematic Assessment | Moderate sedation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Javitt | Nathan Kline Institute | 8453986534 | javitt@nki.rfmh.org |
| Mar 11, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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