Clinical trial NCT02769507: Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Official title: Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Helse-Bergen HF
First posted: 2016-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Auditory Hallucination Rating Scale (AHRS)
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Questionnaire for Psychotic Experiences (QPE)
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Hallucinations App
timeFrame: Continuously between baseline and 3 months after treatment
measure: Hallucination Change Scale (HCS)
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
Secondary outcomes:
measure: Stroop task
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Trailmaking test A and B
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Expectations Questionnaire
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Adverse Effects Questionnaire
timeFrame: The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program
measure: The Clinical Global Impressions Scale - Severity
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Global Assessment of Functioning
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Shape, size, and integrity of gray and white matter structures in the brain
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: BOLD (Blood Oxygenation Level Dependent signal) response during resting state
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Dichotic listening paradigm
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: Dichotic listening paradigm
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: BOLD response during dichotic listening paradigm
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
measure: White matter structure and connectivity
timeFrame: Change from Baseline to immediately after treatment and 3 months after treatment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Marco Hirnstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: