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SchizophreniafuNEEGNCT07856368

Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations

A study testing Neuronavigated repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia and Auditory Verbal Hallucinations, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Auditory verbal hallucinations (AVH), such as hearing voices in the absence of an external sound source, are a common and distressing symptom of schizophrenia. In some patients, hallucinations persist despite treatment with antipsychotic medication. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Auditory Verbal Hallucinations
What is being tested?
Neuronavigated repetitive transcranial magnetic stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSwitzerland
Study dates
11 Jun 2026to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent provided prior to participation
  • Age 18 to 65 years
  • Medication-resistant auditory hallucinations, defined as:
  • At least two adequate trials of antipsychotic medication
  • At least one of these trials with an atypical antipsychotic medication
  • At least five episodes of auditory hallucinations per day during the preceding month
Show all 10Show fewer
  • Stable antipsychotic medication for at least 6 weeks
  • Current treatment at the Psychiatric University Hospital Zurich (PUK), either in an outpatient clinic, day clinic, or inpatient ward
  • Sufficient knowledge of German to understand the study procedures and assessments
  • Ability to follow study procedures

Who cannot join

  • Contraindications to TMS treatment, including cochlear implants, metallic devices close to the TMS coil, history of stroke, head injury, or seizures/epilepsy
  • History of epileptic convulsive seizures or epileptiform potentials in previous EEG examinations
  • TMS treatment within the 3 months preceding study inclusion
  • Known severe hypersensitivity or severe adverse reaction to TMS
  • Pregnancy or breastfeeding
  • Intention to become pregnant during the study
Show all 16Show fewer
  • Major somatic comorbidities, such as renal failure, hepatic dysfunction, heart failure, or cardiovascular disease
  • Current treatment with any drug that lowers the seizure threshold
  • Known or suspected non-compliance, drug abuse, or alcohol abuse
  • Vulnerable subjects (children, pregnant women, elderly persons)
  • Inability to follow study procedures, for example due to language problems, psychological disorder, dementia, or other conditions interfering with participation
  • Participation in another study involving investigational treatment within the 30 days preceding study inclusion or during the present study
  • Current electroconvulsive therapy (ECT)
  • Previous enrollment in the present study
  • Investigator, family member of the investigator, employee, or other dependent person
  • Contraindications or limitations related to the medical device as specified in the instructions for use

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sebastian Olbrich, Prof. Dr. med. contact

0041 58 384 26 37

sebastian.olbrich@pukzh.ch

Switzerland1 site, 1 recruiting
  • Psychiatric University Hospital Zurich

    Zurich, 8032

    Tobias Welt, Dr. med., 0041 58 384 93 40, tobias.welt@pukzh.ch

    Sebastian Olbrich, Prof. Dr. med., 0041 58 384 26 37, sebastian.olbrich@pukzh.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Functional Neuronavigated EEG and TMS-treatment of Chronic Acoustic Hallucinations

Auditory verbal hallucinations (AVH), such as hearing voices in the absence of an external sound source, are a common and distressing symptom of schizophrenia. In some patients, hallucinations persist despite treatment with antipsychotic medication. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may reduce auditory hallucinations by decreasing activity in brain regions involved in auditory and language processing.

This randomized, double-blind, sham-controlled study will investigate whether individualized, neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations. Forty adults with medication-resistant auditory hallucinations will be randomly assigned to receive either active rTMS or sham stimulation.

Read more

For each participant, the stimulation target in the primary auditory cortex will be individually identified using electroencephalography (EEG), acoustic evoked potentials, and magnetic resonance imaging (MRI)-based neuronavigation. Participants will receive two rTMS sessions per day for five consecutive days. The severity of auditory hallucinations will be assessed before and after treatment and at a 28-day follow-up.

The study will also investigate whether treatment is associated with changes in brain activity and functional connectivity measured by EEG, including changes in the P300 event-related potential.

Being tested
Neuronavigated repetitive transcranial magnetic stimulation (rTMS), Sham repetitive transcranial magnetic stimulation (rTMS)
Keywords
Auditory Verbal Hallucinations, Treatment-Resistant Hallucinations, Repetitive Transcranial Magnetic Stimulation, rTMS, Neuronavigation, Electroencephalography, EEG, Auditory Evoked Potentials, Functional Connectivity, P300
Medical subject headings
Schizophrenia, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuronavigated repetitive transcranial magnetic stimulation (rTMS)Device

    Individualized neuronavigated inhibitory rTMS is applied to the primary auditory cortex. The individual stimulation target is determined using EEG-based auditory evoked potentials and MRI-based neuronavigation. Stimulation is delivered at 1 Hz on five consecutive days, with a total of 12,000 magnetic pulses administered over the treatment course.

  • Sham repetitive transcranial magnetic stimulation (rTMS)Device

    Sham stimulation is administered using the same neuronavigation procedures and treatment schedule as active rTMS. A sham coil visually and acoustically resembling the active coil is used but does not deliver active magnetic stimulation.

Study groups in NCT07856368
Study groupRoleWhat they receive
Active rTMSExperimentalParticipants receive individualized, neuronavigated inhibitory rTMS targeting the primary auditory cortex. The stimulation target is individually determined using EEG-based auditory evoked potentials and MRI-based neuronavigation. Treatment is administered twice daily for five consecutive days.
Receives: Device: Neuronavigated repetitive transcranial magnetic stimulation (rTMS)
Sham rTMSSham comparatorParticipants undergo the same treatment schedule and neuronavigation procedures as the active rTMS group using a sham coil that is visually and acoustically similar to the active coil but does not deliver active magnetic stimulation.
Receives: Device: Sham repetitive transcranial magnetic stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score Immediately After Treatment

    Change from baseline in auditory hallucination severity assessed with the Auditory Vocal Hallucination Rating Scale (AVHRS), a structured interview assessing multiple characteristics of auditory hallucinations, including frequency, duration, location, loudness, negative content, distress, interference with daily life, perceived control, anxiety, and interference with thinking.

    Measured: Baseline to immediately after completion of the 5-day treatment period

Secondary outcomes (19)
  1. Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score at Day 28

    Change from baseline in auditory hallucination severity assessed with the Auditory Vocal Hallucination Rating Scale (AVHRS), a structured interview assessing multiple characteristics of auditory hallucinations, including frequency, duration, location, loudness, negative content, distress, interference with daily life, perceived control, anxiety, and interference with thinking.

    Measured: Baseline to Day 28 after completion of treatment

  2. Change From Baseline in PSYRATS Auditory Hallucinations Subscale Score Immediately After Treatment

    Change from baseline in the Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 11 items scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate greater auditory hallucination severity.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  3. Change From Baseline in PSYRATS Delusions Subscale Score Immediately After Treatment

    Change from baseline in the Delusions subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 6 items scored from 0 to 4, yielding a total score from 0 to 24. Higher scores indicate greater delusion severity.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  4. Change From Baseline in PSYRATS Combined Score Immediately After Treatment

    Change from baseline in the combined Psychotic Symptom Rating Scales (PSYRATS) score, calculated as the sum of the Auditory Hallucinations and Delusions subscale scores. The combined score ranges from 0 to 68, with higher scores indicating greater overall psychotic symptom severity.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  5. Change From Baseline in PSYRATS Auditory Hallucinations Subscale Score at Day 28

    Change from baseline in the Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 11 items scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate greater auditory hallucination severity.

    Measured: Baseline to Day 28 after completion of treatment

  6. Change From Baseline in PSYRATS Delusions Subscale Score at Day 28

    Change from baseline in the Delusions subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 6 items scored from 0 to 4, yielding a total score from 0 to 24. Higher scores indicate greater delusion severity.

    Measured: Baseline to Day 28 after completion of treatment

  7. Change From Baseline in PSYRATS Combined Score at Day 28

    Change from baseline in the combined Psychotic Symptom Rating Scales (PSYRATS) score, calculated as the sum of the Auditory Hallucinations and Delusions subscale scores. The combined score ranges from 0 to 68, with higher scores indicating greater overall psychotic symptom severity.

    Measured: Baseline to Day 28 after completion of treatment

  8. Change From Baseline in Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q) Total Score Immediately After Treatment

    Change from baseline in the total score of the Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q), a self-report measure assessing characteristics and severity of auditory vocal hallucinations. Higher scores indicate greater severity of auditory vocal hallucinations.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  9. Change From Baseline in Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q) Total Score at Day 28

    Change from baseline in the total score of the Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q), a self-report measure assessing characteristics and severity of auditory vocal hallucinations. Higher scores indicate greater severity of auditory vocal hallucinations.

    Measured: Baseline to Day 28 after completion of treatment

  10. Change From Baseline in Self-assessment of Auditory Verbal Hallucinations (SAVH) Total Score Immediately After Treatment

    Change from baseline in the total score of the Self-assessment of Auditory Verbal Hallucinations (SAVH), a 9-item self-report measure assessing auditory verbal hallucinations during the preceding week. Each item is scored from 0 to 5, yielding a total score from 0 to 45. Higher scores indicate greater severity of auditory verbal hallucinations.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  11. Change From Baseline in Self-assessment of Auditory Verbal Hallucinations (SAVH) Total Score at Day 28

    Change from baseline in the total score of the Self-assessment of Auditory Verbal Hallucinations (SAVH), a 9-item self-report measure assessing auditory verbal hallucinations during the preceding week. Each item is scored from 0 to 5, yielding a total score from 0 to 45. Higher scores indicate greater severity of auditory verbal hallucinations.

    Measured: Baseline to Day 28 after completion of treatment

  12. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Immediately After Treatment

    Change from baseline in illness severity assessed using the Clinical Global Impression-Severity (CGI-S) scale. CGI-S is rated from 1 to 7, with higher scores indicating greater illness severity.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  13. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 28

    Change from baseline in illness severity assessed using the Clinical Global Impression-Severity (CGI-S) scale. CGI-S is rated from 1 to 7, with higher scores indicating greater illness severity.

    Measured: Baseline to Day 28 after completion of treatment

  14. Clinical Global Impression-Improvement (CGI-I) Score Immediately After Treatment

    Overall change in clinical condition assessed using the Clinical Global Impression-Improvement (CGI-I) scale. CGI-I is rated from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse.

    Measured: Immediately after completion of the 5-day treatment period

  15. Clinical Global Impression-Improvement (CGI-I) Score at Day 28

    Overall change in clinical condition assessed using the Clinical Global Impression-Improvement (CGI-I) scale. CGI-I is rated from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse.

    Measured: Day 28 after completion of treatment

  16. Change From Baseline in Auditory P300 Parameters Immediately After Treatment

    Change from baseline in auditory P300 event-related potential parameters measured by EEG during an auditory Oddball paradigm. P300 amplitude and latency elicited by target stimuli will be evaluated and compared between baseline and post-treatment recordings.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  17. Change From Baseline in Auditory P300 Parameters at Day 28

    Change from baseline in auditory P300 event-related potential parameters measured by EEG during an auditory Oddball paradigm. P300 amplitude and latency elicited by target stimuli will be evaluated and compared between baseline and Day-28 recordings.

    Measured: Baseline to Day 28 after completion of treatment

  18. Change From Baseline in EEG Functional Connectivity Immediately After Treatment

    Change from baseline in functional brain connectivity assessed using EEG and source localization with low-resolution electromagnetic tomography (LORETA). Treatment-related changes in functional connectivity between cortical brain regions will be evaluated by comparing baseline and post-treatment EEG recordings.

    Measured: Baseline to immediately after completion of the 5-day treatment period

  19. Change From Baseline in EEG Functional Connectivity at Day 28

    Change from baseline in functional brain connectivity assessed using EEG and source localization with low-resolution electromagnetic tomography (LORETA). Treatment-related changes in functional connectivity between cortical brain regions will be evaluated by comparing baseline and Day-28 EEG recordings.

    Measured: Baseline to Day 28 after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start11 Jun 2026
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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
Model description
Participants are randomized in a 1:1 ratio to one of two parallel study arms receiving either active neuronavigated inhibitory rTMS or sham stimulation. Both groups undergo identical study procedures and assessments.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07856368
Sponsor's protocol ID
fuNEEG
Other IDs
Bangerter-Rhyner-Foundation
Acronym
fuNEEG
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be made publicly available. Potential reuse of pseudonymized data may be considered in accordance with participant consent and applicable ethical and data protection requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Neuronavigated repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia and Auditory Verbal Hallucinations, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tobias Welt, MD (0041 58 389 93 40, tobias.welt@pukzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score Immediately After Treatment (time frame: Baseline to immediately after completion of the 5-day treatment period). 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 2 Oct 2026.

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