Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucina… (NCT04222582) | Clinical Trial Compass
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Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia
Canada84 participantsStarted 2019-01-01
Plain-language summary
Many individuals with schizophrenia struggle with auditory verbal hallucinations (AVHs). In some cases, these AVHs can be resistant to medication treatment. Previous research has found that transcranial direct current stimulation (tDCS) can be helpful in treating symptoms in individuals with other psychiatric disorders, such as depression. This study will assess if tDCS is effective in treating AVHs in individuals with schizophrenia. tDCS is a non-invasive form of brain stimulation which uses a weak current to temporarily excite or inhibit underlying cortical regions with small electrodes placed on the scalp. tDCS has been found to improve mental processes, including attention and memory function. In addition to examining the effect of tDCS on AVHs, this study will assess the effects of tDCS on mood as well as brain electrical activity with electroencephalogram (EEG) recordings. As an additional component, participants will be invited to participate in neuroimaging. Using magnetic resonance imaging (MRI), brain activity and structure will be examined before and after tDCS. tDCS will be administered twice daily for 5 consecutive days for a total of 10 sessions. These study findings will contribute to the understanding of the impact of tDCS on AVHs, and will also increase knowledge of sound and memory/cognitive processing in individuals with schizophrenia.
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.
Patients - Inclusion Criteria:
* Primary diagnosis of schizophrenia or schizoaffective disorder
* Clinically stable (discretion of psychiatrist)
* Consistent history of AVHs over the course of illness
* \>3 AVHs per week
* Positive and Negative Syndrome Scale (PANSS) score of \>3
* Primary medications limited to one of the atypical antipsychotics (medications stabilized for 4 weeks prior to enrollment)
Patients - Exclusion Criteria:
* Experiencing an acute psychotic episode
* Current drug/alcohol dependence
* Significant medical illness \& mental retardation/learning disability
* Extra-pyramidal symptoms resulting in disordered movement
* Abnormal audiometric assessment (thresholds for pure tones \>25 dB)
* History of significant neurological issues \& head injuries/concussions resulting in loss of consciousness for \>5 minutes
Healthy Controls - Inclusion Criteria:
* In good physical health
* No history of serious mental health issues
Healthy Controls - Exclusion Criteria:
* Personal history of psychiatric disorder
* Family history of schizophrenia in first degree relatives \& history of mental health issues in first degree relatives that required extensive treatment or hospitalization
* Current/history of substance abuse
* Significant medical illness
* Extra-pyramidal symptoms resulting in movement disorder
* Abnormal audiometric assessment (thresholds for pure tones \>25 dB)
* Significant neurological issues \& head injuries/concussions resulting in loss of consciou…
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
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
Timeframe: Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS)