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Идёт набор NCT06118268

iTBS to Enhance Social Cognition in People With Psychosis

Без фазы С лечением Schizophrenia Schizo Affective Disorder Schizophreniform Disorders Psychosis Nos/Other

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: iTBS (Active), iTBS (Sham).
Кому может быть актуально
Состояния в реестре: Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Psychosis Nos/Other. Базовые параметры: 18 лет — 39 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are: * Compare changes in social cognitive performance between the active vs. sham treatment groups * Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.

Вмешательства

  • Устройство iTBS (Active)
    The present study is a double-blind, randomized clinical trial that will examine if iTBS applied to DMPFC improves social cognitive performance compared to sham stimulation DMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).
  • Устройство iTBS (Sham)
    DMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).

Первичные конечные точки

  • Change in social cognitive performance [Срок оценки: From baseline to 4 weeks]
  • Change in social cognitive performance [Срок оценки: From baseline to 4 weeks]
  • Change in social cognitive performance [Срок оценки: From baseline to 4 weeks]
Вторичные конечные точки (1)
  • Change in social cognitive network functional connectivity [Срок оценки: From baseline to 4 weeks]

Критерии участия

Критерии включения

  • Age 18-39 years.
  • DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).
  • Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).
  • Able to participate in the informed consent process and provide voluntary informed consent.

Критерии исключения

  • A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.
  • Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset < 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
  • Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
  • Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
  • Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher due to the potential of these medications to limit the efficacy of iTBS
  • Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
  • Prior Psychosurgery
  • Presence of MRI contraindications (e.g., pacemakers)
  • Pregnancy
  • TMS treatment in the past three months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Zucker Hillside Hospital — Glen Oaks

Публикации

  • Oliver LD, Blumberger DM, Deng ZD, Hawco C, Dickie EW, Gallucci J, Jeyachandra J, Mansour S, Hare SM, Gold JM, Foussias G, Argyelan M, Daskalakis ZJ, Buchanan RW, Malhotra AK, Voineskos AN. Effects of Personalized Transcranial Magnetic Stimulation on Social Cognitive Network Functional Connectivity in Schizophrenia Spectrum Disorders: A Double-Blind, Randomized, Sham-Controlled Target Engagement T PMID 42526755

Идентификаторы

NCT: NCT06118268 · 23-0071

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗