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Remediation of Auditory Recognition in Schizophrenia With tDCS

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial direct current stimulation (tDCS)
Sham Transcranial direct current stimulation (tDCS)
Auditory Remediation
Control computer activities
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Auditory remediation with active tDCS

Auditory remediation with sham tDCS

Control (computer games with sham tDCS)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Auditory Tone Matching Task
Ability to match tones following brief delay

Secondary Outcome Measures

Auditory Emotion Recognition (AER) Task
Ability to detect emotion based on tone of voice
ER-40
Penn Emotion Recognition Test-40 Faces Version
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.
Auditory Mismatch Negativity (MMN)
Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)

Full Information

First Posted
July 19, 2016
Last Updated
June 16, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
Nathan Kline Institute for Psychiatric Research
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1. Study Identification

Unique Protocol Identification Number
NCT02869334
Brief Title
Remediation of Auditory Recognition in Schizophrenia With tDCS
Official Title
Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Nathan Kline Institute for Psychiatric Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auditory remediation with active tDCS
Arm Type
Experimental
Arm Description
Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Arm Title
Auditory remediation with sham tDCS
Arm Type
Experimental
Arm Description
Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Arm Title
Control (computer games with sham tDCS)
Arm Type
Sham Comparator
Arm Description
Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week
Intervention Type
Device
Intervention Name(s)
Active Transcranial direct current stimulation (tDCS)
Intervention Description
Active tDCS, where an extremely weak electric current passes through the brain
Intervention Type
Device
Intervention Name(s)
Sham Transcranial direct current stimulation (tDCS)
Intervention Description
Sham (inactive or placebo) tDCS
Intervention Type
Behavioral
Intervention Name(s)
Auditory Remediation
Intervention Description
Computer program designed to improve discrimination between sounds
Intervention Type
Behavioral
Intervention Name(s)
Control computer activities
Intervention Description
Computer program (e.g. games), which are not designed to improve discrimination between sounds
Primary Outcome Measure Information:
Title
Auditory Tone Matching Task
Description
Ability to match tones following brief delay
Time Frame
Change in performance from Baseline at completion of training (week 16)
Secondary Outcome Measure Information:
Title
Auditory Emotion Recognition (AER) Task
Description
Ability to detect emotion based on tone of voice
Time Frame
Change in performance from Baseline at completion of training (week 16)
Title
ER-40
Description
Penn Emotion Recognition Test-40 Faces Version
Time Frame
Change in performance from Baseline at completion of training (week 16)
Title
The Awareness of Social Inference Test (TASIT)
Description
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.
Time Frame
Change in performance from Baseline at completion of training (week 16)
Title
Auditory Mismatch Negativity (MMN)
Description
Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)
Time Frame
Change in performance from Baseline at completion of training (week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Javitt, MD, PhD
Organizational Affiliation
NY State Psychiatric Institute, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33539561
Citation
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.
Results Reference
derived
Links:
URL
http://nyspi.org/
Description
New York State Psychiatric Institute
URL
http://columbiapsychiatry.org/
Description
Department of Psychiatry, Columbia University Medical Center

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Remediation of Auditory Recognition in Schizophrenia With tDCS

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