Neuroplasticity in RBD

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05471960
Status
Recruiting
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Conditions

  • REM Sleep Behavior Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Natural progression over time — OTHER
    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).

Study Details

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.

Key Dates

Start date
Apr 21, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: iRBD Group: Progression over time
    Each subject be assessed at baseline and approximately 2 years later. At each time point, each participant 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).
  • Other: Control Group: Progression over time
    Each subject be assessed at baseline and approximately 2 years later. At each time point, each participant 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).

Primary Outcome Measure

MRI Progression over 30 to 36 months [ Time Frame: 30 to 36 months from baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Madison Wylie, MS
[email protected]
612-505-8325
Colum MacKinnon, PhD (PRINCIPAL_INVESTIGATOR)

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