RecruitingNot ApplicableNCT06361160

Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation

Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation: Towards a Closed-loop System

Sponsor

Centre Hospitalier St Anne

Enrollment

20 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment-resistant Schizophrenia

Summary

Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system. The research project comprises two phases: -Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions. Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing brain stimulation therapy — a non-invasive technique that uses magnetic or electrical pulses to target specific areas of the brain — to reduce auditory verbal hallucinations (AVH), commonly known as "hearing voices," in people with schizophrenia who have not responded to medications. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with schizophrenia - You hear voices (auditory verbal hallucinations) frequently — at least 10 times per hour - Your voices have not gotten better despite trying at least two different antipsychotic medications at adequate doses - Your antipsychotic medication dose has been stable for at least 30 days - Hearing voices is your main remaining symptom **You may NOT be eligible if...** - You are pregnant - You have epilepsy or a history of seizures - You have metal implants in your head (e.g., cochlear implants, deep brain stimulators) - You have another serious neurological condition - You currently have severe substance use problems 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

DEVICEActive Transcranial Magnetic Stimulation (TMS)

Active rTMS (continuous theta burst, cTBS) applied to the temporo-parietal junction (TPJ) at the onset of the Auditory Verbal Hallucinations (AVH).

DEVICESham Transcranial Magnetic Stimulation (TMS)

Sham rTMS (continuous theta burst, cTBS) applied to the temporo-parietal junction (TPJ) during the onset of the Auditory Verbal Hallucinations (AVH). An electrical stimulator is synchronised with the magnetic stimulation to recreate the tactile sensation and the coils emits the same noise during sham stimulation as in the active configuration, making it impossible to distinguish between active and placebo magnetic stimulation.