Auditory Hallucination, VerbalNCT04222582
Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia
A study testing Transcranial direct current stimulation (tDCS) in people with Auditory Hallucination, Verbal, run by University of Ottawa at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Hallucination, Verbal
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 consciousness for >5 minutes
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z7K4
Bronwen Schryver, B.Sc., 800-987-6424 ext. 6094, bronwen.schryver@theroyal.ca
Verner Knott, PhD, C.Psych
About this study
Official title: The Neural, Behavioural, and Cognitive Outcomes of Transcranial Direct Current Stimulation (tDCS) for Persistent Auditory Verbal Hallucinations in Schizophrenia
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.
- Conditions
- Auditory Hallucination, Verbal
- Being tested
- Transcranial direct current stimulation (tDCS)
- Keywords
- Schizophrenia, Transcranial direct current stimulation (tDCS), Schizoaffective disorder, EEG, Brain imaging, Cognition
- Medical subject headings
- Hallucinations, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Administration 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). Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | Administration 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. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Open-label Active tDCS | Other | Subjects 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. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Healthy Control | No intervention | Healthy volunteers will complete the same questionnaires, EEG recording procedures, and neuroimaging scans as the schizophrenia patient group, but will not undergo tDCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Voice Power Differential Scale (VPDS) is a 7-item scale used to measure the perceived power differences between the voice and the voice hearer. Each item is rated on a five-point scale (1-5), with higher scores indicating greater power differential in favour of the voices, with total scores ranging from 7-35.
Measured: 3 weeks (baseline to follow-up)
Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores
The BAVQ-R is a 35-item questionnaire assessing people's beliefs about auditory hallucinations, and their emotional and behavioural reactions to them. All responses are rated on a 4-point scale: disagree (0); unsure (1); agree slightly (2); agree strongly (3), the measure thus assesses degree of endorsement of items. The scale consists of five subscales: malevolence (score range 0-18), benevolence (0-18), omnipotence (0-18), resistance (0-27), and engagement (0-24).
Measured: 3 weeks (baseline to follow-up)
Change in Voices Acceptance and Action Scale (VAAS) Scores
The VAAS was developed to assess acceptance-based or action-based beliefs in response to auditory verbal hallucinations, in general and specifically to command hallucinations. This 31-item scale is divided into section A (i.e., 12 item stand-alone scale for general auditory hallucinations) and section B, referring specifically to command hallucinations. The participant is asked to rate their opinion from 1 'Strongly Disagree' to 5 'Strongly Agree', with higher scores meaning higher levels of acceptance and perception of acting according to one's valued life directions. Section A scores can range from 12-60, while section B scores can range from 19-95.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Alpha Power
Changes in resting-state EEG power in alpha band. Resting-state recordings completed in both eyes-closed and eyes-open conditions, 5 minutes each.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Beta Power
Changes in resting-state EEG power in beta band. Resting-state recordings completed in both eyes-closed and eyes-open conditions, 5 minutes each.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Delta Power
Changes in resting-state EEG power in delta band. Resting-state recordings completed in both eyes-closed and eyes-open conditions, 5 minutes each.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Theta Power
Changes in resting-state EEG power in theta band. Resting-state recordings completed in both eyes-closed and eyes-open conditions, 5 minutes each.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Gamma Power
Changes in resting-state EEG power in gamma band. Resting-state recordings completed in both eyes-closed and eyes-open conditions, 5 minutes each.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Mismatch Negativity (MMN)
Change in MMN peak amplitudes and latencies to non-speech (tonal) deviants and speech (syllabic) deviants during the multi-feature optimal MMN paradigm.
Measured: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - P50
Change in T/C ratio (testing stimulus/conditioning stimulus) during paired click test.
Change in T/C difference (testing stimulus - conditioning stimulus) during paired click test
Measured: 3 weeks (baseline to follow-up)
Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Resting-State
Changes in resting-state activity and connectivity within and between the auditory cortex and select regions of the default-mode network.
Measured: 3 weeks (baseline to follow-up)
Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Mismatch Negativity (tonal)
Changes in task-related activity and connectivity within and between the auditory cortex and select regions of the default-mode network .
Measured: 3 weeks (baseline to follow-up)
Change in Brain Magnetic Resonance Spectroscopy (MRS)
Changes in glutamate/glutamine (Glu/Gln) concentrations in the auditory cortex.
Measured: 3 weeks (baseline to follow-up)
Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Schizophrenia Battery
Changes in cognitive functioning abilities in core domains often affected in psychosis.
Measured: 3 weeks (baseline to follow-up)
Change in Social Cognition - Social Attribution Task
Changes in social cognition/social inference abilities measured by a computerized social attribution task.
Measured: 3 weeks (baseline to follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Hallucination, VerbalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre
- Responsible party
- Principal investigator, Dr. Verner Knott, University of Ottawa
- Investigators
- Verner Knott, PhD, C.Psych, Principal investigator, University of OttawaNatalia Jaworska, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222582
- Sponsor's protocol ID
- 2017020
- Status last verified
- Jan 2020
- First submitted
- 15 Apr 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural, Behavioural, and Cognitive Outcomes of Transcranial Direct Current Stimulation (tDCS) for Persistent Auditory Verbal Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT04222582
- Acronym / sponsor ID
- 2017020
- Conditions
- Auditory Hallucination, Verbal
- Keywords
- Schizophrenia, Transcranial direct current stimulation (tDCS), Schizoaffective disorder, EEG, Brain imaging, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- The Royal Ottawa Mental Health Centre
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)Administration 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 comparator | Device: Transcranial direct current stimulation (tDCS)Administration 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 | Other | Device: Transcranial direct current stimulation (tDCS)Subjects 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 intervention | –Healthy volunteers will complete the same questionnaires, EEG recording procedures, and neuroimaging scans as the schizophrenia patient group, but will not undergo tDCS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS)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. | Device | Active tDCS, Open-label Active tDCS, Sham tDCS |
Primary outcome
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
Time frame: Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS)
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.
15 secondary outcomes
Change in Voice Power Differential Scale (VPDS) Scores
Time frame: 3 weeks (baseline to follow-up)
Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores
Time frame: 3 weeks (baseline to follow-up)
Change in Voices Acceptance and Action Scale (VAAS) Scores
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Alpha Power
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Beta Power
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Delta Power
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Theta Power
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Resting-State Gamma Power
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - Mismatch Negativity (MMN)
Time frame: 3 weeks (baseline to follow-up)
Change in Electroencephalography (EEG) - P50
Time frame: 3 weeks (baseline to follow-up)
Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Resting-State
Time frame: 3 weeks (baseline to follow-up)
Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Mismatch Negativity (tonal)
Time frame: 3 weeks (baseline to follow-up)
Change in Brain Magnetic Resonance Spectroscopy (MRS)
Time frame: 3 weeks (baseline to follow-up)
Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Schizophrenia Battery
Time frame: 3 weeks (baseline to follow-up)
Change in Social Cognition - Social Attribution Task
Time frame: 3 weeks (baseline to follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verner Knott, PhD, C.Psych principal investigator
University of Ottawa
Natalia Jaworska, PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Auditory Hallucination, Verbal, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bronwen Schryver, B.Sc. (613 722 6521 ext. 6094, bronwen.schryver@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS) (time frame: Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.