Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
Healthy Volunteers
NCT05471960

Neuroplasticity in RBD

Led by University of Minnesota · Updated on 2026-05-04

86

Participants Needed

1

Research Sites

417 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neuroplasticity in RBD

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of polysomnogram-confirmed isolated REM Sleep Behavior Disorder (iRBD) for the iRBD group
  • Age between 21 and 75 years
  • Able to walk independently without an assistive device (e.g., cane or walker) for 50 meters
  • For control group: Age between 21 and 75 years
  • For control group: Able to walk independently without an assistive device for 50 meters
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia or impaired capacity to consent as measured by UBACC and MacCAT-CR
  • History of musculoskeletal disorders significantly affecting limb movement
  • Other significant neurological disorders affecting participation or performance
  • Antidepressant-associated RBD or worsening dream enactment after starting antidepressants
  • Diagnosis of Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, Alzheimer's disease, or other neurodegenerative disorders or known causes of RBD such as narcolepsy or drug-induced RBD
  • Untreated sleep-disordered breathing
  • Pregnant women
  • History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (exclusion from TMS experiments)
  • Recent frequent fainting episodes triggered by blood, emotional stress, or sensory inputs (exclusion from TMS experiments)
  • Presence of intracranial metallic or magnetic devices, pacemakers, or implanted devices (exclusion from TMS experiments)
  • History of surgery on blood vessels, brain, or heart (exclusion from TMS experiments)
  • Unexplained recurring headaches or concussion within six months (exclusion from TMS experiments)
  • Severe hearing impairment (exclusion from TMS experiments)
  • Use of medications affecting neuroplasticity testing such as haloperidol, prazosin, biperiden, dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs, lithium, lovastatin, and cannabis (exclusion from TMS experiments)
  • For control group: History of dream enactment or suspected iRBD
  • For control group: Untreated sleep-disordered breathing
  • For control group: Presence of parkinsonism, cognitive impairment, dementia, or mild cognitive impairment
  • For control group: Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication affecting cognition, neuropsychiatric, motor, or autonomic function

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

M

Madison Wylie, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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