Remediation of Auditory Recognition in Schizophrenia With tDCS

New York State Psychiatric Institute

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Device: Active Transcranial direct current stimulation (tDCS); Behavioral: Control computer activities; Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT02869334

7266

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups

Auditory remediation with active tDCS

Experimental group

Description:

Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week

Treatment:

Behavioral: Auditory Remediation

Device: Active Transcranial direct current stimulation (tDCS)

Auditory remediation with sham tDCS

Experimental group

Description:

Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week

Treatment:

Behavioral: Auditory Remediation

Device: Sham Transcranial direct current stimulation (tDCS)

Control (computer games with sham tDCS)

Sham Comparator group

Description:

Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week

Treatment:

Behavioral: Control computer activities

Device: Sham Transcranial direct current stimulation (tDCS)