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Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations (fuNEEG)

23. September 2026 aktualisiert von: Psychiatric University Hospital, Zurich

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.

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Schweiz
      • Zurich, Schweiz, 8032
        • Rekrutierung
        • Psychiatric University Hospital Zurich
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Tobias Welt, Dr. med.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Active rTMS

Participants 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.
Gerät: Neuronavigated repetitive transcranial magnetic stimulation (rTMS)

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.
Schein-Komparator: Sham rTMS

Participants 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.
Gerät: Sham repetitive transcranial magnetic stimulation (rTMS)

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in PSYRATS Auditory Hallucinations Subscale Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in PSYRATS Delusions Subscale Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in PSYRATS Combined Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in PSYRATS Auditory Hallucinations Subscale Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in PSYRATS Delusions Subscale Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in PSYRATS Combined Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q) Total Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in Auditory Vocal Hallucination Rating Scale Questionnaire (AVHRS-Q) Total Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in Self-assessment of Auditory Verbal Hallucinations (SAVH) Total Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in Self-assessment of Auditory Verbal Hallucinations (SAVH) Total Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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.
Baseline to Day 28 after completion of treatment
Clinical Global Impression-Improvement (CGI-I) Score Immediately After Treatment
Zeitfenster: Immediately after completion of the 5-day treatment period

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.
Immediately after completion of the 5-day treatment period
Clinical Global Impression-Improvement (CGI-I) Score at Day 28
Zeitfenster: Day 28 after completion of 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.
Day 28 after completion of treatment
Change From Baseline in Auditory P300 Parameters Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in Auditory P300 Parameters at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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 Day-28 recordings.
Baseline to Day 28 after completion of treatment
Change From Baseline in EEG Functional Connectivity Immediately After Treatment
Zeitfenster: Baseline to immediately after completion of the 5-day treatment period

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.
Baseline to immediately after completion of the 5-day treatment period
Change From Baseline in EEG Functional Connectivity at Day 28
Zeitfenster: Baseline to Day 28 after completion of 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 Day-28 EEG recordings.
Baseline to Day 28 after completion of treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Psychiatric University Hospital, Zurich

Ermittler

  • Studienleiter: Sebastian Olbrich, Prof. Dr. med., Psychiatrische Universitätsklinik Zürich

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. Juni 2026

Primärer Abschluss (Geschätzt)

1. November 2028

Studienabschluss (Geschätzt)

1. November 2028

Studienanmeldedaten

Zuerst eingereicht

23. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2026

Zuerst gepostet (Tatsächlich)

2. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • fuNEEG
  • Bangerter-Rhyner-Foundation (Andere Zuschuss-/Finanzierungsnummer: Gottfried & Julia Bangerter-Rhyner-Stiftung)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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