Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
Healthy Volunteers
ID05471960

Neuroplasticity in REM Sleep Behavior Disorder

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

86

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

REM sleep behavior disorder (RBD) is a sleep condition linked to brain changes involving alpha-synuclein proteins, which often predict future development of Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy. This research studies brain changes and their progression over 30 to 36 months in people with RBD compared to matched healthy controls. The goal is to understand how brain adaptations during early disease stages may delay visible symptoms and diagnosis. Participants will undergo a series of assessments at the start of the study and again about two years later. Each visit includes eight sessions covering MRI brain scans, transcranial magnetic stimulation (TMS) tests targeting motor and prefrontal brain regions, motor function tests, neuropsychological evaluations, and overnight sleep studies using polysomnography. These measures aim to track changes in brain connectivity, excitability, and clinical signs over time. During the study, participants will attend multiple visits involving detailed brain imaging, motor and cognitive testing, and sleep monitoring. The research team will measure changes in brain structure and function, mood, memory, and cognitive tests such as the Beck Depression Inventory and various dementia rating scales. Participants will be observed over several years to monitor disease progression and brain changes, with safety and consent carefully managed throughout the trial.

CONDITIONS

Brief 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
  • Ability to walk independently without an assistive device for 50 meters
  • Age between 21 and 75 years
  • For control group: age 21 to 75 years and ability 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
  • History of musculoskeletal disorders significantly affecting limb movement
  • Other significant neurological disorders affecting study participation
  • Antidepressant-associated REM sleep behavior disorder
  • Diagnosis of Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, Alzheimer's disease, or other neurodegenerative disorders
  • Untreated sleep-disordered breathing
  • Pregnant women
  • History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (for TMS experiments)
  • Recent frequent syncope episodes
  • Presence of intracranial metallic or magnetic devices
  • Presence of pacemakers or implanted devices
  • History of surgery on blood vessels, brain, or heart
  • Unexplained recurring headaches or concussion within last six months
  • Severe hearing impairment
  • 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
  • Control group exclusions: history of dream enactment suggesting iRBD, untreated sleep-disordered breathing, parkinsonism, cognitive impairment, active CNS or psychiatric conditions, or use of psychoactive medications affecting cognition or motor function

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At baseline

Participants undergo baseline assessments including MRI scanning, TMS-motor and TMS-prefrontal tests, motor assessments, neuropsychological testing, and overnight sleep testing (polysomnography).

8 visits (in-person) at baseline

Long-term Monitoring

Duration - Approximately 2 years

Participants are monitored for natural progression over time. Follow-up assessments include the same testing sessions as baseline to evaluate changes over approximately 2 years.

8 visits (in-person) approximately 2 years after baseline

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

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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