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Search / Trial NCT05471960

Neuroplasticity in RBD

Launched by UNIVERSITY OF MINNESOTA · Jul 20, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

I Rbd

ClinConnect Summary

This clinical trial is studying a condition called REM Sleep Behavior Disorder (RBD), which is a sleep disorder where people act out their dreams. Researchers are interested in how changes in the brain, known as neuroplasticity, might affect the way this disorder develops over time. They will look at brain activity and structure in individuals with RBD compared to those without the disorder over a period of 30 to 36 months. The goal is to understand how these brain changes relate to motor skills and mental health symptoms, which can be crucial for early diagnosis and treatment.

To participate in this study, individuals must be between 21 and 75 years old and able to walk independently for a short distance. Those with diagnosed RBD will be included, but people with certain neurological disorders, dementia, or who have had specific surgeries will not be eligible. Participants can expect to undergo brain imaging and other assessments, and those who qualify will contribute to important research that could help improve understanding and treatment of RBD and related conditions.

Gender

ALL

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

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Colum MacKinnon, Ph.D

Principal Investigator

University of Minnesota

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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