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Clinical Trials/NCT02869334
NCT02869334CompletedNot Applicable

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

New York State Psychiatric Institute1 site in 1 country20 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Auditory Tone Matching Task

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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

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)

Outcomes

Primary Outcomes

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

  • The Awareness of Social Inference Test (TASIT)(Change in performance from Baseline at completion of training (week 16))
  • Auditory Emotion Recognition (AER) Task(Change in performance from Baseline at completion of training (week 16))
  • ER-40(Change in performance from Baseline at completion of training (week 16))
  • Auditory Mismatch Negativity (MMN)(Change in performance from Baseline at completion of training (week 16))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel C. Javitt

Professor

New York State Psychiatric Institute

Study Sites (1)

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