Actively Recruiting
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Led by University of Minnesota · Updated on 2025-07-08
60
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of polysomnogram-confirmed REM sleep behavior disorder (RBD) with dream enactment starting within 2 months of beginning serotonergic antidepressant
- Age between 18 and 75 years
- Use of serotonergic medication (Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline) for at least 6 months without dream enactment (for control participants)
- Age and sex matched controls to 5-HT RBD participants
You will not qualify if you...
- Younger than 18 or older than 75 years
- Diagnosis of Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, Alzheimer's disease, or other neurodegenerative disorders
- Known causes of RBD such as narcolepsy
- Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea, or other sleep-disordered breathing
- History of speech disorders interfering with assessment
- Reduced capacity to consent
- MRI contraindications for 7T scans, including metallic implants or devices
- History of allergic reaction to local anesthesia (xylocaine)
- Pregnant women
- History of dream enactment or increased REM motor tone suggestive of RBD in control participants
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
J
Joy Schmidt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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