Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia
The Neural, Behavioural, and Cognitive Outcomes of Transcranial Direct Current Stimulation (tDCS) for Persistent Auditory Verbal Hallucinations in Schizophrenia
1 other identifier
interventional
84
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJanuary 10, 2020
January 1, 2020
2 years
April 15, 2019
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
The PSYRATS is a multidimensional measure of auditory hallucinations, including 11 items rated on five-point (0-4) scales (total score range 0-44). Symptoms are rated over the last week, with higher scores reflecting more severe symptoms. The dimensions assessed are frequency, duration, location, loudness, beliefs about origin, negative content, intensity of negative content, amount of distress, intensity of distress, disruption of life and control.
Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS)
Secondary Outcomes (15)
Change in Voice Power Differential Scale (VPDS) Scores
3 weeks (baseline to follow-up)
Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores
3 weeks (baseline to follow-up)
Change in Voices Acceptance and Action Scale (VAAS) Scores
3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Alpha Power
3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Beta Power
3 weeks (baseline to follow-up)
- +10 more secondary outcomes
Study Arms (4)
Active tDCS
ACTIVE COMPARATORAdministration of a 2 milliamp (mA) current delivered via two scalp electrodes for 20 minutes (ramp-in + ramp-out periods, 30s total) 2 times per day for 5 consecutive days, \>3 hour interval between sessions, for a total of 10 tDCS sessions. tDCS will be administered with a constant current regulator (NeuroConn DC-Stimulator Plus®, Germany) using 2 saline-soaked sponge electrodes applied over the scalp. Using the 10-20 international EEG system for tDCS electrode placement, the anode will be positioned midway between F3 and Fp1 (left DLPFC) and the cathode midway between T3 and P3 (left TPJ).
Sham tDCS
SHAM COMPARATORAdministration of 2mA tDCS for 30 seconds followed by 19.5 minutes of no current via two scalp electrodes for 20 min (2X/day for 5 consecutive days) with \>3 hours interval between sessions, for a total of 10 tDCS sessions.
Open-label Active tDCS
OTHERSubjects who have received sham tDCS will be given the option to subsequently receive 10 sessions of open-label active tDCS (2X/day for 5 consecutive days) with \>3 hours interval between sessions, for a total of 10 tDCS sessions.
Healthy Control
NO INTERVENTIONHealthy volunteers will complete the same questionnaires, EEG recording procedures, and neuroimaging scans as the schizophrenia patient group, but will not undergo tDCS.
Interventions
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- In good physical health
- No history of serious mental health issues
- 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 consciousness for \>5 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ottawalead
- The Royal Ottawa Mental Health Centrecollaborator
Study Sites (1)
Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z7K4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Verner Knott, PhD, C.Psych
University of Ottawa
- PRINCIPAL INVESTIGATOR
Natalia Jaworska, PhD
University of Ottawa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
April 15, 2019
First Posted
January 10, 2020
Study Start
January 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
January 10, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share