Transcranial Direct Current Stimulation and Effects on Early Auditory Processing in Schizophrenia

NCT03537703 | Completed FDA Device

• 1 other identifier: PCC 2017-080780
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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, the investigators propose to examine the benefit of combining auditory training exercises with transcranial direct current stimulation (tDCS). tDCS is a new tool that is being developed as a safe and noninvasive 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 added to auditory training exercises can improve how schizophrenia patients process sound.

Conditions

Schizophrenia

Keywords

Transcranial Direct Current Stimulation; tDCS; Auditory Processing; tone matching

Outcome Measures

Primary Outcomes (1)

• tone matching

  Performance based measure of tone discrimination

  40 min after last stimulation/training condition

Study Arms (3)

Active tDCS + Auditory Training

EXPERIMENTAL

Cathodal tDCS plus concurrent active auditory training exercise

Combination Product: Active tDCS + Auditory Training

Active tDCS + Control Condition

ACTIVE COMPARATOR

Cathodal tDCS plus concurrent control condition

Combination Product: Active tDCS + Control Condition

Sham tDCS + Auditory Training

ACTIVE COMPARATOR

Sham tDCS plus concurrent active auditory training exercise

Combination Product: Sham tDCS + Auditory Training

Interventions

Active tDCS + Auditory Training COMBINATION_PRODUCT

Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ

Active tDCS + Auditory Training

Active tDCS + Control Condition COMBINATION_PRODUCT

Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The control condition will be subjects watching a silent movie for 20 min during active tDCS stimulation.

Active tDCS + Control Condition

Sham tDCS + Auditory Training COMBINATION_PRODUCT

Sham tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 1 min with the current then slowly ramped down to 0 amps over the course of another minute. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ

Sham tDCS + Auditory Training

Eligibility Criteria

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

You may qualify if:

• age 18-65 yrs
• At least 3 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
• At least 6 months since any behaviors suggesting any potential danger to self or others; adherence to the regular administration of an antipsychotic medication if prescribed; dose of antipsychotic medication not varying by more than 25% over the 3 months prior to study participation;
• Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation;
• Ability to provide signed informed consent and to cooperate with study procedures.
• Able to understand spoken English sufficiently to comprehend testing procedures

You may not qualify if:

• History of treatment with electroconvulsive therapy within 6 months prior to study participation;
• Documented history of persistent substance use disorder within 6 months prior to study participation
• Acute medical problems
• Metallic hardware on the scalp
• Prior diagnosis of seizure or epilepsy
• Subjects requiring proxy consent or consent from a legally authorized representative (LAR)

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Walter Dunn

  VA Medical Center-West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham tDCS
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: May 20, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)