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Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations

RecruitingNAAges 18 Years - 65 YearsAllPsychiatric University Hospital, Zurich
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In plain words

What the trial is, and whether it could suit you

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 identifi

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Neuronavigated repetitive transcranial magnetic stimulation (rTMS)
  • Sham repetitive transcranial magnetic stimulation (rTMS)
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Where

1 site
Psychiatric University Hospital Zurich
Zurich, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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