Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS)

NCT02620267 | Completed

• 1 other identifier: 2015-050587
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Individuals with schizophrenia have difficulties in functioning in the community. No one really knows what factors determine how well patients manage in the real world. The purpose of this pilot study is to try a new approach to improving a potential determinant of good community functioning, namely how we process sounds. Specifically, we propose to examine the benefit of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving processing of sounds. Transcranial direct current stimulation involves placing a wet sponge electrode on the head and one on the arm. Electrical current from a device powered by a 9-volt battery will flow from one electrode to the other. A small portion of the current will pass through the skull and stimulate the brain. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Neurons are brain cells that send electrochemical messages to each other. Its safety and beneficial effect on mental functions has been demonstrated in healthy individuals and several clinical populations. The purpose of this study is to determine if transcranial direct current stimulation can effect how we process sounds.

Conditions

Schizophrenia

Keywords

Mismatch Negativity; Transcranial Direct Current Stimulation; MMN; tDCS

Outcome Measures

Primary Outcomes (1)

• Mismatch Negativity- Auditory Oddball Paradigm

  20 min after each stimulation condition

Secondary Outcomes (1)

• Tone Matching Task

  40 min after each stimulation condition

Study Arms (1)

tDCS Stimulation

EXPERIMENTAL

Each subject will receive all three types of stimulation on separate days- anodal, cathodal, and sham stimulation

Device: tDCS Stimulation

Interventions

tDCS Stimulation DEVICE

Subjects will receive tDCS stimulation over the auditory cortex for 20 min. For anodal stimulation the anode electrodes will be placed over the auditory cortex. For cathodal stimulation, the cathode electrodes will be placed over the auditory cortex. For sham stimulation, the anode electrodes will be placed over the auditory cortex and current turned on for 30 sec before being turned off to simulate the sensation of active stimulation.

tDCS Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-V diagnosis of Schizophrenia
• Estimated premorbid IQ \> 70 (based on WRAT reading ability)
• Understand spoken English sufficiently to comprehend testing procedures
• Clinically stable: no psychiatric inpatient hospitalization in the last three months, no significant changes in their antipsychotic medications during the previous 6 weeks, and no significant changes in their living situation in the last two months based on data from the registry and self-report
• Ability to provide signed informed consent and cooperate with study procedures

You may not qualify if:

• No metal in the cranium, intracardiac lines, cardiac pacemaker, medication pump, or increased intracranial pressure
• No clinically significant neurological or other medical disease as determined by medical history (e.g., seizure disorder, stroke, heart disease, degenerative disease)
• No history of serious head injury (e.g., loss of consciousness more than 1 hour)
• No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
• No evidence moderate or severe drug or alcohol use disorder in the past six months, and not intoxicated at time of testing
• No pregnancy

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MIRECC Research Fellow

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: December 15, 2015
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05