| NCT ID | NCT05471960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | REM Sleep Behavior Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 86 participants |
| Start Date | 2023-04-21 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 86 participants in total. It began in 2023-04-21 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Colum MacKinnon, Ph.D
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05471960 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying REM Sleep Behavior Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05471960 currently recruiting?
Yes, NCT05471960 is actively recruiting participants. Contact the research team at aasen056@umn.edu for enrollment information.
Where is the NCT05471960 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05471960 clinical trial?
NCT05471960 is sponsored by University of Minnesota. The principal investigator is Colum MacKinnon, Ph.D at University of Minnesota. The trial plans to enroll 86 participants.