Recruiting

Neuroplasticity

Sponsor:

University of Minnesota

Code:

NCT05471960

Conditions

REM Sleep Behavior Disorder

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Natural progression over time

Study Details

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

Study ID

NCT05471960

Start date

Apr 21, 2023

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

86 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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).

Interventions

Natural 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).

Primary outcome measure

  • MRI Progression over 30 to 36 months [ Time Frame: 30 to 36 months from baseline ]
  • Change in Beck Depression Inventory score [ Time Frame: 30 to 36 months from baseline ]
  • Change in Mattis Dementia Rating Scale [ Time Frame: 30 to 36 months from baseline ]
  • Change in Rey Complex Figure [ Time Frame: 30 to 36 months from baseline ]
  • Change in WAIS-IV Matrix Reasoning [ Time Frame: 30 to 36 months from baseline ]
  • Change in Stroop Color [ Time Frame: 30 to 36 months from baseline ]
  • Change in Stroop Word [ Time Frame: 30 to 36 months from baseline ]
  • Change in Stroop Color Word [ Time Frame: 30 to 36 months from baseline ]
  • Change in Wisconsin Card Sorting Test [ Time Frame: 30 to 36 months from baseline ]
  • Change in D-KEFS [ Time Frame: 30 to 36 months from baseline ]
  • Change in BVMT-R [ Time Frame: 30 to 36 months from baseline ]
  • Change in HVLT [ Time Frame: 30 to 36 months from baseline ]
  • Change in WMS-3 Spatial Span [ Time Frame: 30 to 36 months from baseline ]
  • Change in Boston Naming Test [ Time Frame: 30 to 36 months from baseline ]
  • Change in Trail Making Test A [ Time Frame: 30 to 36 months from baseline ]
  • Change in Trail Making Test B [ Time Frame: 30 to 36 months from baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator:

Colum MacKinnon, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • iRBD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-27.