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Идёт набор NCT06785532

Effect of RNS in Treatment-refractory Tourette's Syndrome

Без фазы С лечением Tourette Syndrome

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: Responsive Neurostimulation (RNS).
Кому может быть актуально
Состояния в реестре: Tourette Syndrome. Базовые параметры: 18 лет — 65 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)

Обзор

The study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant Tourette's Syndrome (TR-TS).

Подробное описание

Tourette's Syndrome (TS) is a neurodevelopmental disorder characterized by repetitive, involuntary movements and vocalizations known as tics. It typically manifests in childhood and may persist into adulthood. The prevalence of TS varies globally, affecting approximately 1% of the population. There is a broad spectrum of symptom severity. Treatment-refractory TS (TR-TS) refers to cases where standard therapeutic interventions, such as behavioural therapy and medications, have shown limited effectiveness. TR-TS prevalence is relatively lower but highlights the challenges in managing severe and persistent symptoms. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with personalized responsive neurostimulation (RNS) has the most potential for TR-TS with apparent symptoms. However, the RNS case reports are limited and lack high-quality, evidence-based medical evidence. The stimulation targets of RNS for patients with TS include GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. So, this cohort study focuses on the effectiveness of SEEG-guided RNS on TR-TS patients. Another goal is to study the neuronal activity of the GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC, or other unreported nuclei targets, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and different cognitive tasks.

Some participants will also be invited to join a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional.

Вмешательства

  • Устройство Responsive Neurostimulation (RNS)
    The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Первичные конечные точки

  • Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months [Срок оценки: Baseline to 12 months post-surgery]
Вторичные конечные точки (12)
  • YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • YGTSS: remission. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • YGTSS: response rate. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) Remove [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
  • Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]

Критерии участия

Критерии включения

  • aged 18-65;
  • able to provide written informed consent;
  • have a diagnosis of Tourette's syndrome according to the Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
  • with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15;
  • must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months;
  • must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful;
  • have been on stable comorbid conditions without suicidal ideation for at least six months.

Критерии исключения

  • presence of other psychotic disorders;
  • have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);
  • presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
  • experience difficulty in effectively communicating with investigators;
  • with a history of traumatic brain injury (TBI);
  • with intracranial or cardiovascular stents;
  • substance abuse within the past six months;
  • unstable neurological or coagulation disorders;
  • women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
  • have been involved in other clinical studies within three months before enrollment in this study;
  • any conditions considered by the study group.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06785532 · RNS for TRTS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗