Remediation of Auditory Recognition in Schizophrenia With tDCS

NCT02869334 | Completed Results

• 1 other identifier: 7266
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Auditory Tone Matching Task

  Ability to match tones following brief delay

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

Secondary Outcomes (4)

• 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)

• The Awareness of Social Inference Test (TASIT)

  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)

Study Arms (3)

Auditory remediation with active tDCS

EXPERIMENTAL

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); Behavioral: Auditory Remediation

Auditory remediation with sham tDCS

EXPERIMENTAL

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

Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation

Control (computer games with sham tDCS)

SHAM COMPARATOR

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); Behavioral: Control computer activities

Interventions

Active Transcranial direct current stimulation (tDCS) DEVICE

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

Auditory remediation with active tDCS

Sham Transcranial direct current stimulation (tDCS) DEVICE

Sham (inactive or placebo) tDCS

Auditory remediation with sham tDCS; Control (computer games with sham tDCS)

Auditory Remediation BEHAVIORAL

Computer program designed to improve discrimination between sounds

Auditory remediation with active tDCS; Auditory remediation with sham tDCS

Control computer activities BEHAVIORAL

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

Control (computer games with sham tDCS)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Nathan Kline Institute for Psychiatric Research: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 33539561 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Daniel Javitt
• Organization: Nathan Kline Institute

javitt@nki.rfmh.org

8453986534

Study Officials

• Daniel Javitt, MD, PhD

  NY State Psychiatric Institute, Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 16, 2016
• Study Start: June 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)