REM Sleep Behavior DisorderNCT05471960
Neuroplasticity in RBD
An observational study of REM Sleep Behavior Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Natural progression over time
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 31 Jul 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Madison Wylie, MS, 612-505-8325, aasen056@umn.edu
Colum MacKinnon, PhD
About this study
Official title: 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.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Natural progression over time
- Keywords
- iRBD
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural progression over timeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Natural progression over time | |
| 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). Receives: Other: Natural progression over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Progression over 30 to 36 months
Yes/No whether a change was observed from baseline
Measured: 30 to 36 months from baseline
Change in Beck Depression Inventory score
Higher score means more impairment
Measured: 30 to 36 months from baseline
Change in Mattis Dementia Rating Scale
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Rey Complex Figure
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in WAIS-IV Matrix Reasoning
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Stroop Color
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Stroop Word
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Stroop Color Word
Higher score means less impairment
Measured: 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
Measured: 30 to 36 months from baseline
Change in D-KEFS
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in BVMT-R
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in HVLT
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in WMS-3 Spatial Span
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Boston Naming Test
Higher score means less impairment
Measured: 30 to 36 months from baseline
Change in Trail Making Test A
Higher score means more impairment
Measured: 30 to 36 months from baseline
Change in Trail Making Test B
Higher score means more impairment
Measured: 30 to 36 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Apr 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colum MacKinnon, Ph.D, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471960
- Sponsor's protocol ID
- NEUR-2022-30985
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity in REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT05471960
- Acronym / sponsor ID
- NEUR-2022-30985
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- iRBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iRBD Group: Progression over time | – | Other: Natural progression over timeEach 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 | – | Other: Natural progression over timeEach 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). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural progression over timeEach 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). | Other | Control Group: Progression over time, iRBD Group: Progression over time |
Primary outcome
MRI Progression over 30 to 36 months
Time frame: 30 to 36 months from baseline
Yes/No whether a change was observed from baseline
Change in Beck Depression Inventory score
Time frame: 30 to 36 months from baseline
Higher score means more impairment
Change in Mattis Dementia Rating Scale
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Rey Complex Figure
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in WAIS-IV Matrix Reasoning
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Stroop Color
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Stroop Word
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Stroop Color Word
Time frame: 30 to 36 months from baseline
Higher score means less impairment
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
Change in D-KEFS
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in BVMT-R
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in HVLT
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in WMS-3 Spatial Span
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Boston Naming Test
Time frame: 30 to 36 months from baseline
Higher score means less impairment
Change in Trail Making Test A
Time frame: 30 to 36 months from baseline
Higher score means more impairment
Change in Trail Making Test B
Time frame: 30 to 36 months from baseline
Higher score means more impairment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colum MacKinnon, Ph.D principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Wylie, MS (612-505-8325, aasen056@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Progression over 30 to 36 months (time frame: 30 to 36 months from baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.