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RecruitingNCT05471960Updated Aug 27, 2026

Neuroplasticity in RBD

An observational study in REM Sleep Behavior Disorder, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by University of Minnesota · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • REM Sleep Behavior Disorder

Keywords

  • iRBD
03

In context

REM Sleep Behavior Disorder

101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.

This study's planned enrollment of 86 is below the median of 119 across 48 observational studies indexed under REM Sleep Behavior Disorder.

Browse REM Sleep Behavior Disorder studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Browse University of Minnesota studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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).

Eligibility criteria

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 exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):

    • 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.
    • Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
    • Pacemaker or any implanted device
    • History of surgery on blood vessels, brain, or heart
    • Unexplained, recurring headaches or concussion within the last six months
    • Severe hearing impairment
    • If participant is taking one of the following medications that affects neuroplasticity testing, they will be excluded from the TMS experiment: haloperidol (dopamine antagonist), prazosin (norepinephrine antagonist), biperiden (acetylcholine antagonist), dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs (benzodiazepines), lithium, lovastatin, and cannabis.

Exclusion Criteria for Control subject Group:

  • Same as exclusion criteria as the iRBD group
  • History of dream enactment from either patient report or from a bed partner witness that may suggest iRBD.
  • History of untreated sleep-disordered breathing.
  • Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).
  • Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Groups and cohorts

  • 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: Natural progression over time

  • 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).

    Other: Natural progression over time

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).

06

What researchers measure

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 baseline

  2. Change in Beck Depression Inventory score

    Higher score means more impairment

    Time frame: 30 to 36 months from baseline

  3. Change in Mattis Dementia Rating Scale

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  4. Change in Rey Complex Figure

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  5. Change in WAIS-IV Matrix Reasoning

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  6. Change in Stroop Color

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  7. Change in Stroop Word

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  8. Change in Stroop Color Word

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  9. Change in Wisconsin Card Sorting Test

    Higher score means more impairment for subsections "# persev errors" and FMS; less impairment for subsections "# categories" and conceptualization

    Time frame: 30 to 36 months from baseline

  10. Change in D-KEFS

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  11. Change in BVMT-R

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  12. Change in HVLT

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  13. Change in WMS-3 Spatial Span

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  14. Change in Boston Naming Test

    Higher score means less impairment

    Time frame: 30 to 36 months from baseline

  15. Change in Trail Making Test A

    Higher score means more impairment

    Time frame: 30 to 36 months from baseline

  16. Change in Trail Making Test B

    Higher score means more impairment

    Time frame: 30 to 36 months from baseline

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2023 (actual). Primary completion is estimated for Jul 2027, 51 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2022
First posted
Jul 25, 2022
StartActual
Apr 21, 2023
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05471960
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 25, 2022
Start date
Apr 21, 2023
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Madison Wylie, MS
Contact
aasen056@umn.edu
612-505-8325
Colum MacKinnon, Ph.D
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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