Neuronavigated rTMS for treatment-resistant auditory hallucinations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized, double-blind, sham-controlled trial involving 40 adults with schizophrenia and treatment-resistant auditory verbal hallucinations. Each participant will receive either active neuronavigated rTMS or sham stimulation, with the brain target individualized using EEG, acoustic evoked potentials, and MRI to focus on the primary auditory cortex. The aim is to see if targeted, non-invasive brain stimulation can lessen the frequency and severity of voices while maintaining safety. Participants will be recruited from the Psychiatric University Hospital Zurich and must meet criteria related to duration, stability of medications, and language requirements. Outcomes will compare active versus sham stimulation to determine effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Psychiatric University Hospital Zurich
  Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Tobias Welt, MD
• Email: tobias.welt@pukzh.ch
• Phone: 0041 58 389 93 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.