Neuroplasticity in RBD
- Conditions
- REM Sleep Behavior Disorder
- Interventions
- Other: Natural progression over time
- Registration Number
- NCT05471960
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description iRBD Group: Progression over time Natural 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). Control Group: Progression over time Natural 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 Measures
Name Time Method Change in HVLT 30 to 36 months from baseline Higher score means less impairment
Change in Rey Complex Figure 30 to 36 months from baseline Higher score means less impairment
Change in Stroop Word 30 to 36 months from baseline Higher score means less impairment
Change in Wisconsin Card Sorting Test 30 to 36 months from baseline Higher score means more impairment for subsections "# persev errors" and FMS; less impairment for subsections "# categories" and conceptualization
Change in D-KEFS 30 to 36 months from baseline Higher score means less impairment
Change in BVMT-R 30 to 36 months from baseline Higher score means less impairment
Change in WMS-3 Spatial Span 30 to 36 months from baseline Higher score means less impairment
Change in Trail Making Test A 30 to 36 months from baseline Higher score means more impairment
Change in Stroop Color 30 to 36 months from baseline Higher score means less impairment
Change in Boston Naming Test 30 to 36 months from baseline Higher score means less impairment
Change in Trail Making Test B 30 to 36 months from baseline Higher score means more impairment
MRI Progression over 30 to 36 months 30 to 36 months from baseline Yes/No whether a change was observed from baseline
Change in Beck Depression Inventory score 30 to 36 months from baseline Higher score means more impairment
Change in WAIS-IV Matrix Reasoning 30 to 36 months from baseline Higher score means less impairment
Change in Mattis Dementia Rating Scale 30 to 36 months from baseline Higher score means less impairment
Change in Stroop Color Word 30 to 36 months from baseline Higher score means less impairment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States