Neuroplasticity in RBD

August 24, 2026 updated by: University of Minnesota

Neuroplasticity in REM Sleep Behavior Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Colum MacKinnon, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 62 people with iRBD and 24 healthy age- and sex-matched control subjects will be recruited and enrolled for this project with the goal to complete testing in a least 50 iRBD and 16 control subjects at the 30-36 month follow-up time point (conservatively assuming a maximum 20% dropout rate).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: 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).
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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MRI Progression over 30 to 36 months
Time Frame: 30 to 36 months from baseline
Yes/No whether a change was observed from baseline
30 to 36 months from baseline
Change in Beck Depression Inventory score
Time Frame: 30 to 36 months from baseline
Higher score means more impairment
30 to 36 months from baseline
Change in Mattis Dementia Rating Scale
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Rey Complex Figure
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in WAIS-IV Matrix Reasoning
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Stroop Color
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Stroop Word
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Stroop Color Word
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
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
30 to 36 months from baseline
Change in D-KEFS
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in BVMT-R
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in HVLT
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in WMS-3 Spatial Span
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Boston Naming Test
Time Frame: 30 to 36 months from baseline
Higher score means less impairment
30 to 36 months from baseline
Change in Trail Making Test A
Time Frame: 30 to 36 months from baseline
Higher score means more impairment
30 to 36 months from baseline
Change in Trail Making Test B
Time Frame: 30 to 36 months from baseline
Higher score means more impairment
30 to 36 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Colum MacKinnon, Ph.D, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEUR-2022-30985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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