Effect of RNS in Treatment-refractory Tourette's 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 →
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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