Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations
Recruiting · NCT05550155 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Caen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Caen University Hospital - Caen, France