Maintenance rTMS for persistent auditory verbal 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 is a multicenter, randomized, double-blind, placebo-controlled trial enrolling 120 patients to compare active neuronavigated rTMS versus sham using the same schedule. The active arm receives a two-day intensive protocol (four 20-Hz sessions) followed by maintenance rTMS twice weekly for one month and then every two weeks for three months (total 24 maintenance sessions). Individual stimulation targets are personalized with neuronavigation, and both groups follow the same visit schedule over five months. The study will also measure biomarkers such as serum BDNF and scalp-to-cortex distance to explore predictors of response and distinguish responders from non-responders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female; Age ≥ 18 years ≤ 65 years
* Diagnosis of schizophrenia or schizoaffective disorders according to DSM 5.0 criteria
* Patients treated with at least one antipsychotic medication
* Presence of auditory verbal hallucinations despite the optimization of the antipsychotic dosage for at least 6 weeks. This will be operationalized by a minimum AHRS score \> 10
* Stable medication dosage for at least 6 weeks before the rTMS treatment
* Patient who understands the French language
* The agreement of the curatorship or tutorship in the case of a protected adult
* Willing to comply with scheduled visits, as outlined in the protocol
* Covered by, or having the right to Social Security or European cover
* Informed and written consent

Exclusion Criteria:

* Women who are pregnant
* Patients with contraindications for rTMS (history of epilepsy, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes)
* Patients included or planning to be included in another medical research protocol
* Patients unable to complete the protocol follow-up
* Any brain pathological abnormality known or diagnosed by the cerebral MRI
* Contre-indication for cerebral MRI (metallic fix tooth prosthesis, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes, severe claustrophobia)

Where it's running

• Caen University Hospital
  Caen, France Recruiting

Study contacts

• Principal investigator: Sonia Dollfus — University Caen Normandie
• Study coordinator: Sonia Dollfus, MD-PhD
• Email: dollfus-s@chu-caen.fr
• Phone: 02.31.06.50.18

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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.