NCT07856368Toboroz
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Functional Neuronavigated EEG and TMS-treatment of Chronic Acoustic Hallucinations
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2026. szept. 23.
- Kezdés
- 2026. jún. 11.
- Elsődleges befejezés
- 2028. nov.
- Fő szponzor
- Psychiatric University Hospital, Zurich
- Betegségek
- Skizofrénia
- NCT-szám
- NCT07856368
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 40
- 2026. jún. 11. és az elsődleges befejezés (2028. nov.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- History of epileptic convulsive seizures or epileptiform potentials in previous EEG examinations
- Current treatment with any drug that lowers the seizure threshold
- Known or suspected non-compliance, drug abuse, or alcohol abuse
- Current electroconvulsive therapy (ECT)
- Previous enrollment in the present study
Más betegség
- Contraindications to TMS treatment, including cochlear implants, metallic devices close to the TMS coil, history of stroke, head injury, or seizures/epilepsy
- Known severe hypersensitivity or severe adverse reaction to TMS
- Major somatic comorbidities, such as renal failure, hepatic dysfunction, heart failure, or cardiovascular disease
- Inability to follow study procedures, for example due to language problems, psychological disorder, dementia, or other conditions interfering with participation
Egyéb
- TMS treatment within the 3 months preceding study inclusion
- Pregnancy or breastfeeding
- Intention to become pregnant during the study
- Vulnerable subjects (children, pregnant women, elderly persons)
- Participation in another study involving investigational treatment within the 30 days preceding study inclusion or during 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Psychiatric University Hospital Zurich Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Zurich | Svájc | Toboroz |
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