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Neuroplasticity in RBD | Clinical Trials | Clareo Health

RECRUITINGNA

Neuroplasticity in RBD

Neuroplasticity in REM Sleep Behavior Disorder

NCT05471960•University of Minnesota

Summary

REM sleep behavior disorder is a parasomnia that reflects the presence of alpha-synucleinopathy in the brain and is highly predictive of eventual phenoconversion to Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy over the course of years to decades. Neuroplastic adaptations in the brain during the prodromal stage of disease are thought to mask the expression of motor and non-motor signs and may substantially delay diagnosis during a potentially critical time window. This study will examine the state and progression (over 30 to 36 months) of neuroplastic changes in the excitability of the motor and prefrontal cortex (using transcranial magnetic stimulation), the structural and functional connectivity of the brain (using highfield, 7T, magnetic resonance imaging), and the relationship of these changes to the expression of motor and neuropsychological signs, in a cohort of individuals with REM sleep behavior disorder and matched controls.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Diagnosis of polysomnogram-confirmed isolated iRBD.
•Able to ambulate independently without the use of an assistive device (e.g., cane) for 50 meters.
•Age: 21-75 years.
•Age: 21-75 years.
•Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters.

Exclusion Criteria

•Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent.
•History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment.
•Other significant neurological disorders that may affect participation or performance in the study.
•Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.
•Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).
•Untreated sleep-disordered breathing
•History of musculoskeletal disorders that significantly affect movement of lower or upper limbs as determined at the time of enrollment.
•Pregnant women
•* History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
•* Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.
+10 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

August 1, 2022

Primary Completion Date

August 1, 2030

Completion Date

August 1, 2030

Last Updated

May 2, 2025

Enrollment

ESTIMATED participants

Conditions

REM Sleep Behavior Disorder

Interventions

Natural progression over time

OTHER

Contacts

Josh De Kam

CONTACT

612-626-8052 jadekam@umn.edu

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RECRUITINGNA

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Neuroplasticity in RBD

Inclusion Criteria

Exclusion Criteria

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

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

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