Examining brain changes in REM sleep behavior disorder
Neuroplasticity in REM Sleep Behavior Disorder
NA · University of Minnesota · NCT05471960
This study is trying to see how the brains of people with REM sleep behavior disorder change over time compared to those without the condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05471960 on ClinicalTrials.gov |
What this trial studies
This study investigates the neuroplastic changes in individuals diagnosed with REM sleep behavior disorder (iRBD) over a period of 30 to 36 months. Using advanced techniques like transcranial magnetic stimulation and high-field 7T magnetic resonance imaging, the research aims to assess the excitability of the motor and prefrontal cortex, as well as the brain's structural and functional connectivity. The study will compare these changes in individuals with iRBD to matched control subjects to understand the relationship between neuroplasticity and the expression of motor and neuropsychological signs.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-75 with a diagnosis of polysomnogram-confirmed isolated iRBD who can ambulate independently.
Not a fit: Patients with dementia, significant neurological disorders, or those whose RBD is associated with antidepressant use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and intervention strategies for patients at risk of developing Parkinson's disease and other neurodegenerative conditions.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in understanding neuroplasticity in neurodegenerative diseases.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Colum MacKinnon, Ph.D — University of Minnesota
- Study coordinator: Madison Wylie, MS
- Email: aasen056@umn.edu
- Phone: 612-505-8325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: REM Sleep Behavior Disorder, iRBD