Remediation of Auditory Recognition in Schizophrenia With tDCS

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Device: Active Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation; Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Control computer activities

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auditory remediation with active tDCS; Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Device: Active Transcranial direct current stimulation (tDCS); Active tDCS, where an extremely weak electric current passes through the brain; Behavioral: Auditory Remediation; Computer program designed to improve discrimination between sounds
Experimental: Auditory remediation with sham tDCS; Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Behavioral: Auditory Remediation; Computer program designed to improve discrimination between sounds; Device: Sham Transcranial direct current stimulation (tDCS); Sham (inactive or placebo) tDCS
Sham Comparator: Control (computer games with sham tDCS); Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Device: Sham Transcranial direct current stimulation (tDCS); Sham (inactive or placebo) tDCS; Behavioral: Control computer activities; Computer program (e.g. games), which are not designed to improve discrimination between sounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory Tone Matching Task	Ability to match tones following brief delay	Change in performance from Baseline at completion of training (week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
ER-40	Penn Emotion Recognition Test-40 Faces Version	Change in performance from Baseline at completion of training (week 16)
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)
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)

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: Nathan Kline Institute for Psychiatric Research
• Investigators: Principal Investigator: Daniel Javitt, MD, PhD, NY State Psychiatric Institute, Columbia University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: 7266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO