Psychotic Disorders
Conditions
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.
Interventions
DEVICEDC Stimulator PLUS (NeuroConn)
Sponsors
University of Bergen
Helse-Bergen HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Hallucination Rating Scale (AHRS) | Change from Baseline to immediately after treatment and 3 months after treatment | Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations |
| Hallucination Change Scale (HCS) | Change from Baseline to immediately after treatment | Measure for changes in severity of auditory hallucinations; participants rated in percent how much their symptoms had improved (or worsened). The range is thus -100 (symptoms reduced by 100%) to +100 (symptoms worsened by 100%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Change from Baseline to immediately after treatment and 3 months after treatment | Positive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms |
| Stroop Task | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance |
| Trailmaking Test B | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of visuomotor speed |
| Apathy Evaluation Scale | Before, immediately after treatment, and at 3 month follow-up | Total sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy |
| The Clinical Global Impressions Scale - Severity | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of global functioning; rated by clinician on a 7-point scale, with the severity of illness scale rated from 1 (normal) through to 7 (most severely ill) |
| Global Assessment of Functioning - S | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of global functioning - Symptoms, rated by clinician; measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100, where 0 is severely impacted in daily life by symptoms and 100 is not affected at all |
| Dichotic Listening Paradigm | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of executive functioning, forced left condition, percentage reported from left ear |
| Dichotic Listening Laterality Index | Change from Baseline to immediately after treatment and 3 months after treatment | Measure of language lateralization, laterality index in non-forced condition, laterality index is computed according to formula: LI=\[(R-L)/(R+L)\]\*100, where "L" and "R" are the number of correct left and right ear responses, respectively. values can range between -100 (only syllables from left ear correctly reported and +100 (only correct syllables from right ear reported) |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORMarco Hirnstein, PhD
University of Bergen
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 38 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 13 / 13 | 11 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
None listed