Phase
Condition
Sleep Disorders
Treatment
No intervention
Natural progression over time
Clinical Study ID
Ages 21-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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
Connect with a study center
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
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