Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
- Conditions
- Psychotic Disorders
- Interventions
- Device: DC Stimulator PLUS (NeuroConn)
- Registration Number
- NCT02769507
- Lead Sponsor
- University of Bergen
- Brief Summary
The present study aims to investigate whether transcranial direct current stimulation (tDCS) reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes of tDCS will be examined.
- Detailed Description
The majority of patients with psychosis experience hallucinations, particularly auditory hallucinations are frequent. The hallucinations often leads to massive distress and impairments in social functioning and sometimes even order patients to commit acts of violence against themselves or others. The standard treatment for auditory hallucinations is antipsychotic medication. However, side-effects can be severe and about 25-30% of the patients do not respond to the medication. Transcranial direct current stimulation is a non-invasive brain stimulation technique, which modulates cortical excitability in a pain-free free with mild transient adverse effects, if any. Typically, cortical excitability underneath the anode is boosted while cathodal stimulation has inhibitory effects. Previous studies found that 2 daily sessions of 20 min tDCS for five subsequent days may reduce auditory hallucinations. Investigators want to further assess the efficacy of tDCS in sample that is large enough to detect medium to large effects. In addition, investigators want to investigate the neural mechanisms that underlie the tDCS treatment by examining various neuroimaging parameters before, immediately after treatment, and 3 months after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Diagnosed with schizophrenia spectrum disorder or other psychotic disorder
- Frequent auditory hallucinations (at least 5 times a week).
- Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks.
- Mentally competent for informed consent.
- Provided informed consent.
- Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
- History of seizures, or a history of seizures in first-degree relatives.
- History of eye trauma with a metal object or professional metal workers
- History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
- Skin disease on the scalp on the position of the tDCS electrodes
- Coercive treatment based on a judicial ruling
- Pregnancy in female patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham tDCS DC Stimulator PLUS (NeuroConn) DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period. real tDCS DC Stimulator PLUS (NeuroConn) DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
- Primary Outcome Measures
Name Time Method Questionnaire for Psychotic Experiences (QPE) Change from Baseline to immediately after treatment and 3 months after treatment Measure for severity of hallucinations
Auditory Hallucination Rating Scale (AHRS) Change from Baseline to immediately after treatment and 3 months after treatment Measure for severity of hallucinations
Hallucinations App Continuously between baseline and 3 months after treatment iPhone/iPod application for self-ratings of auditory hallucinations
Hallucination Change Scale (HCS) Change from Baseline to immediately after treatment and 3 months after treatment Measure for changes in severity of auditory hallucinations
Positive and Negative Syndrome Scale (PANSS) Change from Baseline to immediately after treatment and 3 months after treatment Measure for positive and negative symptoms in psychotic disorders
- Secondary Outcome Measures
Name Time Method The Clinical Global Impressions Scale - Severity Change from Baseline to immediately after treatment and 3 months after treatment Measure of global functioning
Adverse Effects Questionnaire The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Stroop task Change from Baseline to immediately after treatment and 3 months after treatment Measure of executive functioning
Trailmaking test A and B Change from Baseline to immediately after treatment and 3 months after treatment Measure of visuomotor speed
Expectations Questionnaire Change from Baseline to immediately after treatment and 3 months after treatment prior expectations participants have regarding the outcome of the treatment on a scale from 0 ("The treatment will have no effect") to 10 ("The treatment will make the voices go away entirely.")
BOLD (Blood Oxygenation Level Dependent signal) response during resting state Change from Baseline to immediately after treatment and 3 months after treatment Resting state functional MRI
Global Assessment of Functioning Change from Baseline to immediately after treatment and 3 months after treatment Measure of global functioning
Shape, size, and integrity of gray and white matter structures in the brain Change from Baseline to immediately after treatment and 3 months after treatment Structural Magnetic Resonance Imaging (MRI)
GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions Change from Baseline to immediately after treatment and 3 months after treatment MR spectroscopy
Dichotic listening paradigm Change from Baseline to immediately after treatment and 3 months after treatment Measure of language lateralization
BOLD response during dichotic listening paradigm Change from Baseline to immediately after treatment and 3 months after treatment Changes in brain activity in the left dorsolateral prefrontal cortex and the peri-Sylvian language regions
White matter structure and connectivity Change from Baseline to immediately after treatment and 3 months after treatment MR Diffusion Tensor Imaging
Trial Locations
- Locations (1)
University of Bergen
🇳🇴Bergen, Hordaland, Norway