Psychotic DisordersNCT02769507
Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
A study testing DC Stimulator PLUS (NeuroConn) in people with Psychotic Disorders, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- DC Stimulator PLUS (NeuroConn)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- DC Stimulator PLUS (NeuroConn)
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC Stimulator PLUS (NeuroConn)Device
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Experimental | 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. Receives: Device: DC Stimulator PLUS (NeuroConn) |
| sham tDCS | Sham comparator | 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. Receives: Device: DC Stimulator PLUS (NeuroConn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Hallucination Rating Scale (AHRS)
Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Hallucination Change Scale (HCS)
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%)
Measured: Change from Baseline to immediately after treatment
Secondary outcomes (8)
Positive and Negative Syndrome Scale (PANSS)
Positive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Stroop Task
Measure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Trailmaking Test B
Measure of visuomotor speed
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Apathy Evaluation Scale
Total sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy
Measured: Before, immediately after treatment, and at 3 month follow-up
The Clinical Global Impressions Scale - Severity
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)
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Global Assessment of Functioning - S
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
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Dichotic Listening Paradigm
Measure of executive functioning, forced left condition, percentage reported from left ear
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Dichotic Listening Laterality Index
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)
Measured: Change from Baseline to immediately after treatment and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Principal investigator, Marco Hirnstein, University of Bergen
- Investigators
- Marco Hirnstein, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769507
- Sponsor's protocol ID
- UiB-BFS-01/2016
- Status last verified
- May 2026
- First submitted
- 6 May 2016
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT02769507
- Acronym / sponsor ID
- UiB-BFS-01/2016
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- Jul 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Experimental | Device: 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. |
| sham tDCS | Sham comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| DC Stimulator PLUS (NeuroConn) | Device | real tDCS, sham tDCS |
Primary outcome
Auditory Hallucination Rating Scale (AHRS)
Time frame: 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)
Time frame: 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%)
8 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Stroop Task
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Trailmaking Test B
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Apathy Evaluation Scale
Time frame: Before, immediately after treatment, and at 3 month follow-up
The Clinical Global Impressions Scale - Severity
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Global Assessment of Functioning - S
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Dichotic Listening Paradigm
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Dichotic Listening Laterality Index
Time frame: Change from Baseline to immediately after treatment and 3 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".
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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.
Marco Hirnstein, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC Stimulator PLUS (NeuroConn) in people with Psychotic Disorders, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 19 May 2026. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Hallucination Rating Scale (AHRS) (time frame: Change from Baseline to immediately after treatment and 3 months after treatment). The study lists 2 primary outcomes in all. 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 19 May 2026.