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Brain scans could reveal early warning signs of Parkinson's

NCT ID NCT05471960

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study looks at how the brain changes over time in people with REM sleep behavior disorder, a condition that often leads to Parkinson's disease or similar disorders. Researchers will use brain scans and thinking tests to track these changes in about 86 adults. The goal is to better understand early signs of disease, which could help with earlier diagnosis in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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Other studies related to the condition(s) this trial covers.