Schizophrenia Clinical Trial
Official title:
Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS): A Pilot Study
Verified date | May 2020 |
Source | VA Greater Los Angeles Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | June 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. DSM-V diagnosis of Schizophrenia 2. Estimated premorbid IQ > 70 (based on WRAT reading ability) 3. Understand spoken English sufficiently to comprehend testing procedures 4. 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 5. Ability to provide signed informed consent and cooperate with study procedures Exclusion Criteria: 1. No metal in the cranium, intracardiac lines, cardiac pacemaker, medication pump, or increased intracranial pressure 2. No clinically significant neurological or other medical disease as determined by medical history (e.g., seizure disorder, stroke, heart disease, degenerative disease) 3. No history of serious head injury (e.g., loss of consciousness more than 1 hour) 4. No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data 5. No evidence moderate or severe drug or alcohol use disorder in the past six months, and not intoxicated at time of testing 6. No pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VA Greater Los Angeles Healthcare System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mismatch Negativity- Auditory Oddball Paradigm | 20 min after each stimulation condition | ||
Secondary | Tone Matching Task | Performance based measure of tone discrimination | 40 min after each stimulation condition |
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