Maintenance rTMS for persistent auditory verbal hallucinations
Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Reducing Auditory Verbal Hallucinations (AVH) With High Frequency and Neuronavigation Guidance: A Double-blind, Randomized and Multicentric Study
This trial tests whether adding regular maintenance rTMS sessions after a two-day intensive rTMS course can reduce persistent hearing voices in adults with schizophrenia or schizoaffective disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT05550155 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 with schizophrenia or schizoaffective disorder who have persistent auditory verbal hallucinations despite at least six weeks of optimized antipsychotic treatment (AHRS > 10), stable medication for six weeks, French-speaking, and able to consent are ideal candidates.
Not a fit: Patients who are pregnant, have contraindications to rTMS (history of epilepsy, implanted electronic or metal devices such as pacemakers or intracranial clips), do not have persistent AVH, have unstable medication, or cannot attend in-person visits are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the maintenance rTMS schedule could prolong and strengthen reduction of auditory verbal hallucinations and improve daily functioning for patients who do not fully respond to medication alone.
How similar studies have performed: Previous randomized, double-blind studies showed that a two-day high-frequency, neuronavigated rTMS protocol can rapidly reduce auditory verbal hallucinations, but extending that effect with a structured multi-month maintenance program is a novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Caen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.