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Идёт набор NCT03887663

Chinese PD Registry

Наблюдательное Parkinson Disease

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: Без ограничений · 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

The Chinese Parkinson's Disease Registry

Обзор

The purpose of the Chinese Parkinson's disease Registry (CPDR) is to develop a database of patients with Parkinson's disease in China.

Подробное описание

Parkinson's disease (PD) is the second most common disorder among degenerative neurological diseases. PD is a complicated disease which consists of different subtypes. A certain type of parkinsonism has its unique clinical feature and genetic basis. Standards of classification and prognosis in different PD subtypes are still poorly understood. Investigators aim to establish a database of longitudinal recruited PD cohort ,and characterize the clinical feature, genetic basis, environmental factors and their interactions among different PD subtypes in China, identify natural history of a highly-presentative Chinese PD cohort and to discern major milestones in the disease process which indicates disease progression.

Data were collected at baseline, 12±1 months during the routine follow-up visits. Information about detailed disease history, level of education, significant chronic comorbidities, physical examination, medication history, family history, living habits and toxic exposure history, which include smoking, drinking tea, alcoholic consumption, drinking coffee, exposure to pesticide or occupational solvent, history of carbon monoxide poisoning and recurrent head trauma will be recorded at baseline. For each evaluation, the same questionnaires will be conducted. A standardized neurological assessment according to the recommendation of Consensus on the construction of clinical database of Parkinson's disease and movement disorders in China. The Unified Parkinson's Disease Rating Scale (UPDRS) part III is conducted for motor assessment, all the patients are evaluated in "OFF" state. The clinical stage of PD is assessed by Hoehn and Yahr scale (H-Y). The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS), autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms (SCOPA-AUT). Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome Ⅲ. The 39-item Parkinson's Disease Qestionnaire (PDQ-39) was used to assess the quality of life. Sleep quality was evaluated by Parkinson's Disease Sleep Scale (PDSS) and excessive daytime sleepiness by Epworth Sleepiness Scale (ESS). Probable rapid eye movement sleep behavior disorder (p-RBD) was diagnosed by rapid eye movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire (CH-RLSq). Cognitive assessment was used the previously validated scale, Mini Mental State Examination (MMSE). Olfaction test was carried out by Hyposmia Rating Scale (HRS), a proportion of patients was also ascertained by Sniffin's Sticks. Depression was diagnosed by Hamilton Depression Scale (HAMD). Symptom of fatigue was measured by PD fatigue severity scale (PFS). Wearing-off was evaluated by WOQ-9 and freezing gait by new freezing gait questionnaire scores (NFOGQ). Dyskinesis was evaluated by Rush Dyskinesia Rating Scale. DNA samples extracted from peripheral blood and all the PD patients will be examed by Whole Exome Sequencing or Whole-genome sequencing. All the participants are scanned by structural MRI to exclude obvious intracranial lesions and other parkinsonism such as MSA, PSP and WD.

Первичные конечные точки

  • The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes [Срок оценки: 12±1 months]
  • The clinical stage of PD is assessed by Hoehn and Yahr scale [Срок оценки: 12±1 months]
  • Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms [Срок оценки: 12±1 months]
  • The non-motor symptoms are evaluated by Non-motor Symptom Scale [Срок оценки: 12±1 months]
  • Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III. [Срок оценки: 12±1 months]
  • The PDQ-39 was used to assess the quality of life. [Срок оценки: 12±1 months]
  • Sleep quality is evaluated by Parkinson's Disease Sleep Scale [Срок оценки: 12±1 months]
  • Excessive sleepiness is evaluated by Epworth Sleepiness Scale [Срок оценки: 12±1 months]
  • Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong [Срок оценки: 12±1 months]
  • Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire [Срок оценки: 12±1 months]
Вторичные конечные точки (3)
  • hypertension [Срок оценки: baseline]
  • Type II diabetes [Срок оценки: baseline]
  • Hyperlipidemia [Срок оценки: baseline]

Критерии участия

Критерии включения

  • Patients diagnosed with PD by UK Brain Bank Diagnostic Criteria and other standard criteria.

Критерии исключения

  • Lack of capacity to consent to participate in the project

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Xiangya Hospital of Central South University — Changzhi

Идентификаторы

NCT: NCT03887663 · CPDR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗