Neuroplasticity in RBD
ConditionREM Sleep Behavior Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-75
SponsorUniversity of Minnesota
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A total of 62 people with iRBD and 24 healthy age- and sex-matched control subjects will be recruited and enrolled for this project with the goal to complete testing in a least 50 iRBD and 16 control subjects at the 30-36 month follow-up time point (conservatively assuming a maximum 20% dropout rate).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Natural progression over time
Other interventionEach 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).
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: iRBD Group: Progression over time1 intervention
Group B: Control Group: Progression over time1 intervention
Trial outcomes
Primary outcomes
1
MRI Progression over 30 to 36 months
Yes/No whether a change was observed from baseline
Time frame
30 to 36 months from baseline2
Change in Beck Depression Inventory score
Higher score means more impairment
Time frame
30 to 36 months from baseline3
Change in Mattis Dementia Rating Scale
Higher score means less impairment
Time frame
30 to 36 months from baseline4
Change in Rey Complex Figure
Higher score means less impairment
Time frame
30 to 36 months from baselineSponsors and contacts
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Source ClinicalTrials.gov