Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder

Официальное название

Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder

Обзор

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development.

Вмешательства

• Другое Thermo test pain
  Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand.
• Другое Pain questionnaires
  Patients will complete various questionnaires about pain
• Другое No motors symptoms evaluations
  Patients will complete questionnaires

Первичные конечные точки

• Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients [Срок оценки: 2 hours after the inclusion]

Вторичные конечные точки (5)

• Describe semiological characteristics of pain in RBD patients [Срок оценки: 2 hours after the inclusion]
• Compare the presence of chronic pain [Срок оценки: 2 hours after the inclusion]
• Assessing Pain Characteristics [Срок оценки: 2 hours after the inclusion]
• Assessment of thermal pain threshold and tolerance [Срок оценки: 2 hours after the inclusion]
• Assessment of correlations between the intensity of chronic pain [Срок оценки: 2 hours after the inclusion]

Критерии участия

Критерии включения

• Diagnosed with iRBD confirmed by polysomnography;
• No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease;
• Ability to understand and complete study procedures and questionnaires;

Control group:

• Diagnosed with narcolepsy type 1;
• Coexisting REM sleep behavior disorder confirmed by polysomnography;
• Ability to understand and complete study procedures and questionnaires;

Критерии исключения

• Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy;
• Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V);
• Inability to complete study procedures or questionnaires.

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

Диагностика

Центры проведения

Франция · 1 центр

• Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac — Toulouse

Идентификаторы

NCT: NCT07365566 · RC31/25/0567 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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