RecruitingNot ApplicableNCT05550155

Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in 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


Sponsor

University Hospital, Caen

Enrollment

120 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ongoing (maintenance) sessions of a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) can help reduce persistent auditory hallucinations — hearing voices — in people with schizophrenia or schizoaffective disorder. **You may be eligible if...** - You are between 18 and 65 years old - You have a diagnosis of schizophrenia or schizoaffective disorder - You are taking antipsychotic medication - You continue to hear voices despite optimized medication (for at least 6 weeks) - Your medication dose has been stable for at least 6 weeks - You understand French **You may NOT be eligible if...** - You are pregnant or may become pregnant - You have metal implants in your head or a pacemaker (contraindications for rTMS) - You have a history of seizures - You have a serious, unstable medical condition - You have a substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS) Treatment

a 4-month maintenance procedure of active rTMS

DEVICESham Repetitive Transcranial Magnetic Stimulation (rTMS)

a 4-month maintenance procedure of sham rTMS


Locations(1)

Caen University Hospital

Caen, France

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NCT05550155


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