Neuroplasticity in RBD

NCT05471960 | Recruiting

• 1 other identifier: NEUR-2022-30985
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

REM Sleep Behavior Disorder

Keywords

iRBD

Outcome Measures

Primary Outcomes (16)

• MRI Progression over 30 to 36 months

  Yes/No whether a change was observed from baseline

  30 to 36 months from baseline

• Change in Beck Depression Inventory score

  Higher score means more impairment

  30 to 36 months from baseline

• Change in Mattis Dementia Rating Scale

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Rey Complex Figure

  Higher score means less impairment

  30 to 36 months from baseline

• Change in WAIS-IV Matrix Reasoning

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Stroop Color

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Stroop Word

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Stroop Color Word

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Wisconsin Card Sorting Test

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

  30 to 36 months from baseline

• Change in D-KEFS

  Higher score means less impairment

  30 to 36 months from baseline

• Change in BVMT-R

  Higher score means less impairment

  30 to 36 months from baseline

• Change in HVLT

  Higher score means less impairment

  30 to 36 months from baseline

• Change in WMS-3 Spatial Span

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Boston Naming Test

  Higher score means less impairment

  30 to 36 months from baseline

• Change in Trail Making Test A

  Higher score means more impairment

  30 to 36 months from baseline

• Change in Trail Making Test B

  Higher score means more impairment

  30 to 36 months from baseline

Study Arms (2)

iRBD Group: Progression over time

OTHER

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

OTHER

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

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).

Control Group: Progression over time; iRBD Group: Progression over time

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Colum MacKinnon, Ph.D

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Wylie, MS

CONTACT

612-505-8325; aasen056@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessor will be blind to the group status during data processing and analyses
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective (assessments at baseline and 24 months) cross sectional design. Two groups (iRBD, controls)

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)