Temporal Interference Stimulation (TI) for Schizophrenia (SCZ)

Korábbi kezelés

• Receipt of TI, another form of transcranial electrical stimulation, or electroconvulsive therapy within the preceding 6 months.
• Participation in another interventional clinical study within 3 months before screening, or current participation in another study that may affect evaluation of efficacy or safety in this study.

Más betegség

• History of a suicide attempt, or a score of 3 or higher on item 3 (suicidal ideation) of the 17-item Hamilton Depression Rating Scale at screening.
• A current DSM-5 diagnosis of another major psychiatric disorder, such as bipolar disorder, major depressive disorder with psychotic features, schizoaffective disorder, or substance/medication-induced psychotic disorder.
• A major neurological disorder, such as organic brain damage or severe traumatic brain injury.
• A contraindication to TI or MRI, including an implanted electronic device; MRI-incompatible intracranial or other metallic implants; wounds or active infection of the scalp at electrode contact sites; severe allergy to electrodes or conductive materials; severe claustrophobia; inability to lie supine; or another condition judged by the investigator to make TI or MRI unsuitable.
• Alcohol or another psychoactive substance use disorder within the preceding 6 months, or urine/blood toxicology at screening indicating recent use of illicit psychoactive substances.
• A history of seizures, a clear familial risk of epilepsy, or use of medication that substantially lowers the seizure threshold and cannot be adjusted.
• Severe or unstable physical illness, including uncontrolled cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, serious systemic infection, malignancy, or severe endocrine/metabolic abnormalities, that may increase study risk or interfere with study completion in the investigator's judgment.
• Severe aggression or impulsivity, agitation, delirium, impaired consciousness, or another acute condition that prevents safe cooperation with TI, MRI, or clinical assessments.
• Significant cognitive impairment, intellectual disability, language or hearing impairment, or another condition that prevents understanding of study requirements, completion of assessments, or provision of reliable information.
• Anticipated poor adherence, difficulty completing follow-up, or any other condition that, in the investigator's judgment, would compromise participant safety or rights, interfere with study completion, or affect interpretation of the study results.

Egyéb

• Pregnancy or breastfeeding.

• Age 18 to 60 years.
• Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Positive and Negative Syndrome Scale (PANSS) total score of at least 60 at screening.
• Initiation, dose adjustment, or switching of antipsychotic medication within the preceding 72 hours.
• The participant or legally authorized representative is able to understand the study procedures and voluntarily provide written informed consent, as applicable.
• Ability to cooperate with MRI scanning, TI treatment, clinical assessments, and follow-up visits during the study.