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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537703
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Walter Dunn, VA Greater Los Angeles Healthcare System

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Combination Product: Active tDCS + Auditory Training Combination Product: Active tDCS + Control Condition Combination Product: Sham tDCS + Auditory Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Sham tDCS
Primary Purpose: Basic Science
Official Title: Transcranial Direct Current Stimulation and Effects on Early Auditory
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Active tDCS + Auditory Training
Cathodal tDCS plus concurrent active auditory training exercise
Combination Product: Active tDCS + Auditory Training
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 Comparator: Active tDCS + Control Condition
Cathodal tDCS plus concurrent control condition
Combination Product: Active tDCS + Control Condition
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 Comparator: Sham tDCS + Auditory Training
Sham tDCS plus concurrent active auditory training exercise
Combination Product: Sham tDCS + Auditory Training
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




Primary Outcome Measures :
  1. tone matching [ Time Frame: 40 min after last stimulation/training condition ]
    Performance based measure of tone discrimination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-65 yrs
  2. At least 3 months since any hospitalization or substantial increase in level of care for an acute exacerbation of psychotic symptoms
  3. 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;
  4. Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation;
  5. Ability to provide signed informed consent and to cooperate with study procedures.
  6. Able to understand spoken English sufficiently to comprehend testing procedures

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537703


Locations
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United States, California
West Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
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Principal Investigator: Walter Dunn VA Medical Center-West Los Angeles
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Responsible Party: Walter Dunn, Staff Psychiatrist, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT03537703    
Other Study ID Numbers: PCC 2017-080780
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Walter Dunn, VA Greater Los Angeles Healthcare System:
Transcranial Direct Current Stimulation
tDCS
Auditory Processing
tone matching
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders