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Набор скоро начнётся NCT04996992

MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

— Наблюдательное Parkinson Disease Magnetic Resonance Imaging

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: MR-guided focused ultrasound.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Magnetic Resonance Imaging. Базовые параметры: от 30 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

Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

Обзор

To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes. Parkinson's disease (PD) is the second most progressive neurodegenerative disease with many motor and non-motor symptoms, which brings heavy burden to the family and the society. MRgFUS pallidothalamic tractotomy allows to address all symptoms of PD without skull opening and with very limited tissue ablation, but with varying effectiveness. The unknown pathogenesis of PD has greatly contributed to this variance. Therefore, in order to optimize the clinical application of MRgFUS pallidothalamic tractotomy, it is important to reveal the pathogenesis of Parkinson's disease by using multiple modality MRI methods, and identify imaging biomarkers to triage suitable candidates and predict clinical outcomes.

Подробное описание

Treatment scheme:

All patients will first receive uni- or bilateral MRgFUS PTT. As to bilateral interventions, the second one will take place at least 6 months after the first PTT. Patients with unilateral intervention will be followed to 1 year. Patients with bilateral interventions will be followed to 1 year after the second intervention. Baseline clinical demographics, Unified Parkinson Disease Rating Scale (UPDRS), treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded.

Imaging protocols:

T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI

Imaging evaluation:

1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1; 2. ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively; 3. ASL shows regional cerebral blood flow associated with the procedure; 4. DTI demonstrates the destruction of white matter integrity. 5. Rs-functional MRI reflects alterations of resting-state brain activity.

Treatment:

MRgFUS pallidothalamic tractotomy

Follow-up:

MRI + clinical evaluation: Baseline, 3-day, 1-week, 1-month, 3-months, 6-months,12-months

Вмешательства

  • Процедура MR-guided focused ultrasound
    MR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients.

Первичные конечные точки

  • primary efficacy outcome [Срок оценки: 1 year]
  • primary safety outcome [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Regardless of sex, aged 30 or above, hope to treat bilateral motor symptoms and receive the other side treatment plan at the 6th month;
  • Subjects are able and willing to give informed consent and can participate in whole study visits;
  • It was clinically diagnosed as Parkinson's disease and confirmed by functional neurosurgeons;
  • The subjects should respond to levodopa;
  • In the off-medication state, the subjects' MDS-UPDRS scores were 30 or more.

Критерии исключения

  • The subjects scored 3 or more in the pull-back test;
  • Parkinson's disease symptoms were suspected as the side effects of antipsychotics;
  • severe cognitive impairment confirmed by neuropsychologists;
  • subjects with other neurodegenerative diseases;
  • Subjects with unstable mental illness, defined as active, uncontrolled depression, schizophrenia, delusions, hallucinations or suicide intention;
  • Pregnant or lactating women;
  • Subjects with alcohol or drug abuse;
  • Subjects with unstable heart condition or severe hypertension;
  • Subjects with a history of abnormal bleeding or clotting.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 1 центр
  • Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT04996992 · MRgFUS-PTT-PD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗