Reducing auditory-verbal hallucinations in schizophrenia using brain stimulation
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation: Towards a Closed-loop System
NA · Centre Hospitalier St Anne · NCT06361160
This study is testing a new brain stimulation method to see if it can help people with schizophrenia who hear voices and haven't found relief with regular medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06361160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with schizophrenia who experience frequent auditory-verbal hallucinations resistant to at least two antipsychotic treatments.
Not a fit: Patients who are pregnant, have neurological disorders, or are currently undergoing anticonvulsant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from treatment-resistant schizophrenia by reducing the frequency and severity of their hallucinations.
How similar studies have performed: Previous studies have shown promise in using TMS for treating auditory-verbal hallucinations, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment Resistant Schizophrenia, Transcranial Magnetic Stimulation