Идёт набор NCT06467461

Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder

Без фазы С лечением Dementia With Lewy Bodies Parkinson Disease REM Sleep Behavior Disorder

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: Skin biopsy, Speech testing, Ultra high field 7T MRI.
Кому может быть актуально: Состояния в реестре: Dementia With Lewy Bodies, Parkinson Disease, REM Sleep Behavior Disorder. Базовые параметры: 18 лет — 75 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy. The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.

Вмешательства

Диагностический тест Skin biopsy
Skin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD
Диагностический тест Speech testing
Speech Testing to quantify evolving signs of 5-HT RBD
Диагностический тест Ultra high field 7T MRI
7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration

Первичные конечные точки

Phosphorylated alpha synuclein deposits on skin biopsy [Срок оценки: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)]
Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex [Срок оценки: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)]
Monopitch as measured by fundamental frequency variability. [Срок оценки: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)]

Вторичные конечные точки (2)

Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex. [Срок оценки: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)]
Speed of articulatory change as measured by F2 Transitions [Срок оценки: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)]

Критерии участия

Критерии включения

Serotonergic REM sleep behavior (5-HT RBD) participants

Критерии включения

Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.
History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants

Критерии включения

Age (±3 years) and sex matched to participants with 5-HT RBD
On serotonergic medication for at least 6 months without history of dream enactment.

The following serotonergic medications will be included:

Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline

Критерии исключения

Serotonergic REM sleep behavior (5-HT RBD) participants

Критерии исключения

Younger than 18
Older than 75
Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
History of dysarthria, aphasia or other condition which could interfere with speech assessment
Reduced capacity to consent
MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, etc.).
History of allergic response to xylocaine or other local anesthesia
Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants

Exclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following: