Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
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
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.
Interventions
DEVICEActive Transcranial direct current stimulation (tDCS)
Active tDCS, where an extremely weak electric current passes through the brain
DEVICESham Transcranial direct current stimulation (tDCS)
Sham (inactive or placebo) tDCS
BEHAVIORALAuditory Remediation
Computer program designed to improve discrimination between sounds
BEHAVIORALControl computer activities
Computer program (e.g. games), which are not designed to improve discrimination between sounds
Sponsors
Nathan Kline Institute for Psychiatric Research
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Tone Matching Task | Change in performance from Baseline at completion of training (week 16) | Ability to match tones following brief delay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Emotion Recognition (AER) Task | Change in performance from Baseline at completion of training (week 16) | Ability to detect emotion based on tone of voice |
| ER-40 | Change in performance from Baseline at completion of training (week 16) | Penn Emotion Recognition Test-40 Faces Version |
| The Awareness of Social Inference Test (TASIT) | Change in performance from Baseline at completion of training (week 16) | 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. |
| Auditory Mismatch Negativity (MMN) | Change in performance from Baseline at completion of training (week 16) | Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Auditory Remediation With Active tDCS | Auditory Remediation With Sham tDCS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 39.0 years STANDARD_DEVIATION 9.9 | 44.7 years STANDARD_DEVIATION 14.4 | 42.4 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
| Tone matching (i.e. ability to match tones following brief delay) | 53.6 percent correct STANDARD_DEVIATION 5.1 | 54.3 percent correct STANDARD_DEVIATION 12.7 | 54.0 percent correct STANDARD_DEVIATION 9.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Auditory Tone Matching Task
Ability to match tones following brief delay
Time frame: Change in performance from Baseline at completion of training (week 16)
Population: completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Remediation With Active tDCS | Auditory Tone Matching Task | -4.3 %correct, different trials | Standard Deviation 12.1 |
| Auditory Remediation With Sham tDCS | Auditory Tone Matching Task | 4.8 %correct, different trials | Standard Deviation 9.3 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Remediation With Active tDCS | Auditory Emotion Recognition (AER) Task | -3.0 %correct | Standard Deviation 8.6 |
| Auditory Remediation With Sham tDCS | Auditory Emotion Recognition (AER) Task | 5.1 %correct | Standard Deviation 12.2 |
Secondary
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)
Population: Subjects who completed post-testing and had usable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Remediation With Active tDCS | Auditory Mismatch Negativity (MMN) | -1.47 microvolt | Standard Deviation 0 |
| Auditory Remediation With Sham tDCS | Auditory Mismatch Negativity (MMN) | -.98 microvolt | Standard Deviation 1.07 |
Secondary
ER-40
Penn Emotion Recognition Test-40 Faces Version
Time frame: Change in performance from Baseline at completion of training (week 16)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Remediation With Active tDCS | ER-40 | -5.0 percent correct | Standard Deviation 3.5 |
| Auditory Remediation With Sham tDCS | ER-40 | -1.3 percent correct | Standard Deviation 1.8 |
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.
Time frame: Change in performance from Baseline at completion of training (week 16)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auditory Remediation With Active tDCS | The Awareness of Social Inference Test (TASIT) | 10 score on a scale | Standard Deviation 4.2 |
| Auditory Remediation With Sham tDCS | The Awareness of Social Inference Test (TASIT) | 0 score on a scale | Standard Deviation 6.8 |