Clinical trial NCT04222582: Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia
Official title: The Neural, Behavioural, and Cognitive Outcomes of Transcranial Direct Current Stimulation (tDCS) for Persistent Auditory Verbal Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auditory Hallucination, Verbal
Keywords: Schizophrenia
Transcranial direct current stimulation (tDCS)
Schizoaffective disorder
EEG
Brain imaging
Cognition
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Royal Ottawa Mental Health Centre
First posted: 2020-01-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change in Voice Power Differential Scale (VPDS) Scores
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Voices Acceptance and Action Scale (VAAS) Scores
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Resting-State Alpha Power
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Resting-State Beta Power
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Resting-State Delta Power
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Resting-State Theta Power
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Resting-State Gamma Power
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - Mismatch Negativity (MMN)
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Electroencephalography (EEG) - P50
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Resting-State
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Mismatch Negativity (tonal)
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Brain Magnetic Resonance Spectroscopy (MRS)
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Schizophrenia Battery
timeFrame: 3 weeks (baseline to follow-up)
measure: Change in Social Cognition - Social Attribution Task
timeFrame: 3 weeks (baseline to follow-up)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Royal Ottawa Mental Health Centre
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Verner Knott, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Natalia Jaworska, PhD
role: PRINCIPAL_INVESTIGATOR
References: