An interventional study of Active Transcranial direct current stimulation (tDCS) and Sham Transcranial direct current stimulation (tDCS) in Schizophrenia and Schizoaffective Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-07-08.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
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) · Behavioral: Auditory Remediation
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) · Behavioral: Auditory Remediation
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) · Behavioral: Control computer activities
Active tDCS, where an extremely weak electric current passes through the brain
Sham (inactive or placebo) tDCS
Computer program designed to improve discrimination between sounds
Computer program (e.g. games), which are not designed to improve discrimination between sounds
Auditory Tone Matching Task
Ability to match tones following brief delay
Time frame: Change in performance from Baseline at completion of training (week 16)
Auditory Emotion Recognition (AER) Task
Ability to detect emotion based on tone of voice
Time frame: Change in performance from Baseline at completion of training (week 16)
ER-40
Penn Emotion Recognition Test-40 Faces Version
Time frame: 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.
Time frame: 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)
Time frame: Change in performance from Baseline at completion of training (week 16)
| Milestone | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| Started | 10 | 10 |
| Completed | 2 | 3 |
| Not completed | 8 | 7 |
Ability to match tones following brief delay
| %correct, different trials | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| Auditory Tone Matching Task | -4.3 ± 12.1 | 4.8 ± 9.3 |
Ability to detect emotion based on tone of voice
| %correct | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| Auditory Emotion Recognition (AER) Task | -3.0 ± 8.6 | 5.1 ± 12.2 |
Penn Emotion Recognition Test-40 Faces Version
| percent correct | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| ER-40 | -5.0 ± 3.5 | -1.3 ± 1.8 |
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.
| score on a scale | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| The Awareness of Social Inference Test (TASIT) | 10 ± 4.2 | 0 ± 6.8 |
Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)
| microvolt | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| Auditory Mismatch Negativity (MMN) | -1.47 ± 0 | -.98 ± 1.07 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auditory Remediation With Active tDCS | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Auditory Remediation With Sham tDCS | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS |
|---|---|---|
| sedationNervous system disorders | 1/2 | 0/3 |
| Age, Categorical(Participants) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| Mean | 39.0 ± 9.9 | 44.7 ± 14.4 | 42.4 ± 11.8 |
| Sex: Female, Male(Participants) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
| Tone matching (i.e. ability to match tones following brief delay)(percent correct) | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| Mean | 53.6 ± 5.1 | 54.3 ± 12.7 | 54.0 ± 9.3 |
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New York State Psychiatric Institute