Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimula… (NCT02620267) | Clinical Trial Compass
CompletedNot Applicable
Target Engagement of the Early Auditory Processing Network by Transcranial Direct Current Stimulation (tDCS)
14 participantsStarted 2015-12-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mismatch Negativity- Auditory Oddball Paradigm
Timeframe: 20 min after each stimulation condition
. 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