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Completed

NCT Number: NCT02869334

Remediation of Auditory Recognition in Schizophrenia With tDCS

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Transcranial Direct Current Stimulation (tDCS)

Device

Active tDCS, where an extremely weak electric current passes through the brain

Sham Transcranial Direct Current Stimulation (tDCS)

Device

Sham (inactive or placebo) tDCS

Auditory Remediation

Behavioral

Computer program designed to improve discrimination between sounds

Control computer activities

Behavioral

Computer program (e.g. games), which are not designed to improve discrimination between sounds

Primary outcomes

  1. Auditory Tone Matching Task

    Time frame: Change in performance from Baseline at completion of training (week 16)

    Ability to match tones following brief delay

Secondary outcomes

  1. Auditory Emotion Recognition (AER) Task

    Time frame: Change in performance from Baseline at completion of training (week 16)

    Ability to detect emotion based on tone of voice

  2. ER-40

    Time frame: Change in performance from Baseline at completion of training (week 16)

    Penn Emotion Recognition Test-40 Faces Version

  3. The Awareness of Social Inference Test (TASIT)

    Time frame: 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.

  4. Auditory Mismatch Negativity (MMN)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Nathan Kline Institute for Psychiatric Research

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2016
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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