Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation

Launched by CENTRE HOSPITALIER ST ANNE · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with treatment-resistant schizophrenia who experience auditory-verbal hallucinations (AVH), which means they hear voices or sounds that others do not. The researchers aim to test a system that uses a special type of brain stimulation called transcranial magnetic stimulation (TMS) to see if they can reduce the duration and intensity of these hallucinations when they occur. The study is divided into two phases: the first involves weekly sessions over 12 weeks, where participants will receive either active or sham (placebo) stimulation, and the second phase offers a standard TMS treatment that has shown positive effects on AVH.

To participate in this trial, individuals must be over 18 years old and diagnosed with schizophrenia, specifically experiencing frequent AVH that have not improved despite trying at least two different medications. Participants should not be pregnant, should not have certain neurological disorders, and must be able to undergo an MRI scan safely. Throughout the study, participants will be monitored closely, and their experiences with the treatment will be evaluated to see if it effectively helps reduce their hallucinations. This trial could provide valuable insights into new treatment options for those struggling with severe symptoms of schizophrenia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years old
• • Schizophrenic Disorder (Diagnostic and statistical manual of mental disorders, DSM-5-TR, American Psychiatric Association, 2013)
• • AVHs that have resisted to at least two properly conducted antipsychotic therapies at an effective dose for at least 8 weeks (criteria of Kinon et al., 1993)
• • Frequent AVHs (at least 10 times per hour) (Fovet et al., 2022)
• • Unmodified antipsychotic dosage for 30 days prior to inclusion in the protocol
• • AVH are the main residual symptom of schizophrenia.
• • Consent to participate in the study
• Exclusion Criteria:
• • Pregnancy (based on date of last menstrual period with possibility of urine test if in doubt)
• • Anticonvulsant therapy
• • Neurological disorder (e.g., multiple sclerosis, epilepsy)
• • Current addictive behavior (except tobacco and cannabis, widely used in this clinical population; Fovet et al., 2022)
• • Contraindication to MRI (i.e., presence of ferromagnetic material or implanted neurostimulation devices due to the risk of displacement or dysfunction such as cochlear implants, cardiac pacemakers, metal splinters in the body following an accident, permanent makeup applied less than 6 months ago, neurosurgical clips, deep brain or vagus nerve stimulation devices, baclofen pumps) (Lefaucheur et al., 2011)
• • Morphological criteria: weight \> 130 Kg, abdominal circumference conditioned by the opening of the magnet, shoulder width
• • Lack of coverage by the social security system
• • Current participation in another interventional research protocol or being in the exclusion period of a previous research protocol
• • Refusal to be informed of an brain anomaly detected in the MRI
• • Person under guardianship or curatorship
• • Behavioral disorders or delusions likely to prevent the MRI or rTMS from being performed under good conditions (left to the discretion of the investigator at baseline).