Меню
Идёт набор NCT06595654

Treatment of Negative Symptoms of Schizophrenia by rTMS

Без фазы С лечением Schizophrenia Negative Symptoms in Schizophrenia

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: repetitive Transcranial Magnetic Stimulation.
Кому может быть актуально
Состояния в реестре: Schizophrenia, Negative Symptoms in Schizophrenia. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study

Обзор

The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).

Вмешательства

  • Другое repetitive Transcranial Magnetic Stimulation
    * Patient is in a chair. * Hearing protection will be implemented. * The corresponding targeting method will be implemented. * The stimulation coil will be set up according to the indications of the targeting method. * A caregiver is present throughout the session. * After the session, the patient is re-assessed clinically for possible adverse effects. * If an adverse reaction is objectified, a doctor on site, is quickly mobilized.

Первичные конечные точки

  • Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms). [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
Вторичные конечные точки (9)
  • Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI. [Срок оценки: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.]
  • Assess the impact of this treatment on response rate by the SANS [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
  • Assess the impact of this treatment on the rate of remission by the number of remission with the SANS [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
  • Assess the impact of this treatment on the relapse rate by the number of relapse with SANS [Срок оценки: 4 weeks, 12 weeks and 24 weeks after the end of treatment.]
  • Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
  • Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test) [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
  • Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia). [Срок оценки: Baseline (day 1) to end of treatment (2 or 4 weeks)]
  • Assess the impact of this treatment on quality of life by S-QoL-18 [Срок оценки: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.]
  • Assess the impact of this treatment on adverse reactions by the CGI [Срок оценки: Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.]

Критерии участия

Критерии включения

  • Patient over 18 years of age
  • Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
  • Stable drug treatment for at least 4 weeks
  • Presence or persistence of negative symptoms in the foreground:

Negative PANSS score ⩾21, positive PANSS score ⩽24

  • Patient (or legal representative) willing to participate in the study and having signed an informed consent
  • Patient fluent in the French language
  • Affiliation to a social security scheme

Критерии исключения

  • Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
  • Presence of an unstabilized medical condition
  • Pregnant woman
  • Woman of childbearing potential and without effective contraception
  • Breastfeeding woman

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Etablissement Public de Santé de Ville-Evrard — Neuilly-sur-Marne

Идентификаторы

NCT: NCT06595654 · 2021-A02710-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗