Remediation of Auditory Recognition in Schizophrenia With tDCS

Schizophrenia Clinical Trial

Official title:

Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869334
• Other study ID #: 7266
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• Active Transcranial direct current stimulation (tDCS)
Active tDCS, where an extremely weak electric current passes through the brain
• Sham Transcranial direct current stimulation (tDCS)
Sham (inactive or placebo) tDCS

Behavioral:
• Auditory Remediation
Computer program designed to improve discrimination between sounds
• Control computer activities
Computer program (e.g. games), which are not designed to improve discrimination between sounds

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory Tone Matching Task	Ability to match tones following brief delay	Change in performance from Baseline at completion of training (week 16)
Secondary	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)
Secondary	ER-40	Penn Emotion Recognition Test-40 Faces Version	Change in performance from Baseline at completion of training (week 16)
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.	Change in performance from Baseline at completion of training (week 16)
Secondary	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)

External Links

•   Department of Psychiatry, Columbia University Medical Center
•   New York State Psychiatric Institute