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New treatment option for REM Sleep Behavior Disorder
Official title Neuroplasticity in RBD
ClinicalTrials.gov ID: NCT05471960
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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. For Control Subject Group:
- Age: 21-75 years.
You likely can't join if
- 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...
- 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...
- Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative...
See the full eligibility 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. 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.
- 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.