Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations (fuNEEG)

23 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svizzera
      • Zurich, Svizzera, 8032
        • Reclutamento
        • Psychiatric University Hospital Zurich
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Tobias Welt, Dr. med.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Comparatore fittizio: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score Immediately After Treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score at Day 28
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Psychiatric University Hospital, Zurich

Investigatori

  • Direttore dello studio: Sebastian Olbrich, Prof. Dr. med., Psychiatrische Universitätsklinik Zürich

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 giugno 2026

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2028

Date di iscrizione allo studio

Primo inviato

23 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2026

Primo Inserito (Effettivo)

2 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • fuNEEG
  • Bangerter-Rhyner-Foundation (Altro numero di sovvenzione/finanziamento: Gottfried & Julia Bangerter-Rhyner-Stiftung)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi