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Neuroplasticity in RBD

Neuroplasticity in REM Sleep Behavior Disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05471960
Enrollment
86
Registered
2022-07-25
Start date
2023-04-21
Completion date
2027-07-31
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REM Sleep Behavior Disorder

Keywords

iRBD

Brief 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.

Interventions

OTHERNatural progression over time

Each subject will attend eight testing sessions (MRI scanning, two TMS-motor test visits, two TMS-prefrontal test visits, motor assessments, neuropsychological testing, and overnight sleep testing (polysomnography - PSG).

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

for the iRBD Group: * 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. Inclusion Criteria For Control Subject Group: * 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

for iRBD group: * 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 * Additional

Design outcomes

Primary

MeasureTime frameDescription
Change in Boston Naming Test30 to 36 months from baselineHigher score means less impairment
Change in Trail Making Test A30 to 36 months from baselineHigher score means more impairment
Change in Trail Making Test B30 to 36 months from baselineHigher score means more impairment
Change in HVLT30 to 36 months from baselineHigher score means less impairment
Change in WMS-3 Spatial Span30 to 36 months from baselineHigher score means less impairment
MRI Progression over 30 to 36 months30 to 36 months from baselineYes/No whether a change was observed from baseline
Change in Beck Depression Inventory score30 to 36 months from baselineHigher score means more impairment
Change in Mattis Dementia Rating Scale30 to 36 months from baselineHigher score means less impairment
Change in Rey Complex Figure30 to 36 months from baselineHigher score means less impairment
Change in WAIS-IV Matrix Reasoning30 to 36 months from baselineHigher score means less impairment
Change in Stroop Color30 to 36 months from baselineHigher score means less impairment
Change in Stroop Word30 to 36 months from baselineHigher score means less impairment
Change in Stroop Color Word30 to 36 months from baselineHigher score means less impairment
Change in Wisconsin Card Sorting Test30 to 36 months from baselineHigher score means more impairment for subsections "# persev errors" and FMS; less impairment for subsections "# categories" and conceptualization
Change in D-KEFS30 to 36 months from baselineHigher score means less impairment
Change in BVMT-R30 to 36 months from baselineHigher score means less impairment

Countries

United States

Contacts

CONTACTMadison Wylie, MS
aasen056@umn.edu612-505-8325
PRINCIPAL_INVESTIGATORColum MacKinnon, Ph.D

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026