Remediation of Auditory Recognition in Schizophrenia With tDCS

NCT ID: NCT02869334

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-01-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Auditory remediation with active tDCS

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

Group Type: EXPERIMENTAL

Active Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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

Auditory Remediation

Intervention Type: BEHAVIORAL

Computer program designed to improve discrimination between sounds

Auditory remediation with sham tDCS

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

Group Type: EXPERIMENTAL

Sham Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Sham (inactive or placebo) tDCS

Auditory Remediation

Intervention Type: BEHAVIORAL

Computer program designed to improve discrimination between sounds

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

Group Type: SHAM_COMPARATOR

Sham Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Sham (inactive or placebo) tDCS

Control computer activities

Intervention Type: BEHAVIORAL

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

Interventions

Active Transcranial direct current stimulation (tDCS)

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

Intervention Type: DEVICE

Sham Transcranial direct current stimulation (tDCS)

Sham (inactive or placebo) tDCS

Intervention Type: DEVICE

Auditory Remediation

Computer program designed to improve discrimination between sounds

Intervention Type: BEHAVIORAL

Control computer activities

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Daniel C. Javitt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Javitt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NY State Psychiatric Institute, Columbia University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33539561 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://nyspi.org/

New York State Psychiatric Institute

http://columbiapsychiatry.org/

Department of Psychiatry, Columbia University Medical Center

Other Identifiers

7266

Identifier Type: -

Identifier Source: org_study_id