Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations

NCT05550155 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Caen

Phase

Not applicable

Started

2023-10-30

Last updated

2025-07-25

Condition(s) studied

Schizophrenia; Psychosis

Investigational drug(s) / intervention(s)

Repetitive Transcranial Magnetic Stimulation (rTMS) TreatmentSham Repetitive Transcranial Magnetic Stimulation (rTMS)

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment: a 4-month maintenance procedure of active rTMS

Sham Repetitive Transcranial Magnetic Stimulation (rTMS): a 4-month maintenance procedure of sham rTMS

Study summary

Repetitive transcranial magnetic stimulation (rTMS) can alleviate persistent auditory verbal hallucinations (AVH) in schizophrenic patients, but the classical procedure with low-frequency stimulation for several weeks upon the left temporoparietal junction have shown modest therapeutic effects, and there is currently no robust predictive factor to the response of the treatment. In a previous multicentric, randomized, and double-blind controlled study, it has been demonstrated that a high-frequency rTMS over an anatomical target can rapidly affect AVHs. Moreover, an intensification of the classical procedure delivering 20-Hz rTMS over a 2-day period was used in addition to a personalized anatomical stimulation target and neuronavigation guidance. Besides the significant efficacy of the procedure, the efficacy was maximal at two weeks after the end of the treatment. In this project, the hypothesis is that the two-day cure could benefit from maintenance rTMS sessions every week for one month and then every two weeks for 3 months to provide an optimal strategy for a long-lasting AVH reduction. This has for now never been tested. Predictive factors to the response of the treatment are also investigated.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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)

Primary outcome measure(s)

the number of times a patient is assessed as a responder — between baseline and month 5
the number of times a patient is assessed as a responder in the active versus the sham group during their follow-up between baseline (D1) and at the end of the maintenance treatment (M5), i.e. the month after the last maintenance session.

Trial sites (1)

Facility	City	Region	Status
Caen University Hospital	Caen	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05550155 on ClinicalTrials.gov ↗ ← All trials in France