Actively Recruiting
Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations
Led by University Hospital, Caen · Updated on 2025-07-25
120
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female; Age 63 18 years 64 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 with 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
You will not qualify if you...
- Women who are pregnant
- Patients with contraindications for rTMS such as 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 cerebral MRI
- Contraindication for cerebral MRI such as metallic fixed 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Caen University Hospital
Caen, France, 14033
Actively Recruiting
Research Team
S
Sonia Dollfus, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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