September 2024
Melanocortins and Endorphins in Restless Legs Syndrome Related Augmentation
The underlying cause of restless legs syndrome (RLS) is unknown. We have previously shown that levels of our body’s naturally occurring opioid hormone, beta-endorphin, are low in patients with RLS and levels of the pain sensitizing melanocortin hormones are high in RLS. These findings may explain why opioid medications are so effective in the treatment of RLS.
The purpose of the current study is to demonstrate these same hormone changes occur in RLS patients with the most severe form of RLS, RLS-related augmentation. Augmentation occurs in RLS patients who have a severe worsening of RLS caused by a dopamine medication, such as ropinirole (requip), pramipexole (Mirapex), or levodopa (sinemet). The study aims to compare beta endorphin and melanocortin system hormones in patients with augmentation to the same patients following proper removal of the dopamine drug and control of RLS.
The study is being conducted at Yale University in New Haven, Connecticut by Dr Brian Koo and is funded in part by a grant from the RLS Foundation. The study requires that patients are having augmentation. Blood and cerebrospinal fluid are sampled during augmentation and after the dopamine drug has been withdrawn. Thus two visits to CT are required. Patients who do not have an RLS physician to oversee the withdrawal of the dopamine medication and the prescription of an appropriate RLS medication alternative may be able to have a clinical visit with Dr. Koo, who will then direct treatment of augmentation. This clinical visit is not part of the research study and is best covered by insurance. Clinical and research visits can be paired. Research visits occur in the evening and last for about 2.5 hours. These research visits will likely be months apart.
To be eligible, you must be between 18 and 79 years old, not be on a blood thinner (aspirin 81mg is OK), and have primary RLS. Exclusion criteria include Parkinson’s disease, multiple sclerosis, renal disease, uncontrolled diabetes, and severe neuropathy. To learn more, please email Emily Rivera Emily.rivera.er842@yale.edu and provide the state in which live and the phone number where you can be reached.
Contact: Emily Rivera Emily at Emily.rivera.er842@yale.edu