Reducing auditory-verbal hallucinations in schizophrenia using brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore a novel approach to treating treatment-resistant schizophrenia by utilizing transcranial magnetic stimulation (TMS) to reduce auditory-verbal hallucinations (AVH). The research involves a closed-loop neuromodulation system that detects AVH in real-time and applies targeted stimulation to interrupt these episodes. Participants will undergo either active or sham TMS to assess the feasibility and effectiveness of this intervention. The study focuses on individuals who have not responded to traditional antipsychotic therapies and experience frequent AVH.

Why it matters

Who can join: the full rules

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).

Where it's running

• Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences
  Paris, France Recruiting

Study contacts

• Principal investigator: Philippe Domenech, MD, PhD — GHU Paris Psychiatry & Neurosciences
• Study coordinator: Philippe Domenech, MD, PhD
• Email: philippe.domenech@ghu-paris.fr
• Phone: (0)1 49 81 22 01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.