Clinical trial NCT02869334: Remediation of Auditory Recognition in Schizophrenia With tDCS
Official title: Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Nathan Kline Institute for Psychiatric Research
First posted: 2016-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Auditory Tone Matching Task
timeFrame: Change in performance from Baseline at completion of training (week 16)
Secondary outcomes:
measure: Auditory Emotion Recognition (AER) Task
timeFrame: Change in performance from Baseline at completion of training (week 16)
measure: ER-40
timeFrame: Change in performance from Baseline at completion of training (week 16)
measure: The Awareness of Social Inference Test (TASIT)
timeFrame: Change in performance from Baseline at completion of training (week 16)
measure: Auditory Mismatch Negativity (MMN)
timeFrame: Change in performance from Baseline at completion of training (week 16)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NY State Psychiatric Institute, Columbia University
name: Daniel Javitt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.