Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06361160
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06361160
Study Brief:
Protocol Section:
NCT06361160