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NCT Number: NCT05471960

Neuroplasticity in RBD

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.

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Key information

Conditions

REM Sleep Behavior Disorder Mental Disorders Nervous System Diseases Parasomnias REM Sleep Parasomnias Sleep Wake Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Colum MacKinnon, PhD

PRINCIPAL_INVESTIGATOR

Madison Wylie, MS

CONTACT

[email protected]

612-505-8325

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. MRI Progression over 30 to 36 months

    Time frame: 30 to 36 months from baseline

    Yes/No whether a change was observed from baseline

  2. Change in Beck Depression Inventory score

    Time frame: 30 to 36 months from baseline

    Higher score means more impairment

  3. Change in Mattis Dementia Rating Scale

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  4. Change in Rey Complex Figure

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  5. Change in WAIS-IV Matrix Reasoning

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  6. Change in Stroop Color

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  7. Change in Stroop Word

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  8. Change in Stroop Color Word

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  9. Change in Wisconsin Card Sorting Test

    Time frame: 30 to 36 months from baseline

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

  10. Change in D-KEFS

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  11. Change in BVMT-R

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  12. Change in HVLT

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  13. Change in WMS-3 Spatial Span

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  14. Change in Boston Naming Test

    Time frame: 30 to 36 months from baseline

    Higher score means less impairment

  15. Change in Trail Making Test A

    Time frame: 30 to 36 months from baseline

    Higher score means more impairment

  16. Change in Trail Making Test B

    Time frame: 30 to 36 months from baseline

    Higher score means more impairment

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Wylie, MS

CONTACT

[email protected]

612-505-8325

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Neuroplasticity in REM Sleep Behavior Disorder

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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