Sleep-specific DBS Therapy in Parkinson's Disease

Launched by UNIVERSITY OF MINNESOTA · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how deep brain stimulation (DBS) therapy can help improve sleep problems in people with Parkinson's disease (PD). Many individuals with PD experience difficulties with sleep, which can significantly affect their quality of life. The researchers want to understand how the brain works during these sleep disturbances and how DBS might change brain activity related to sleep. This study could lead to better treatments for sleep issues in people with neurodegenerative diseases like Parkinson's.

To participate in this trial, you need to be at least 21 years old and have a diagnosis of idiopathic Parkinson's disease. You should also be planning to have a specific type of brain imaging and surgery to implant a DBS system at the University of Minnesota. If you join, you can expect to undergo evaluations that help the researchers learn more about your sleep patterns and how they relate to your Parkinson's disease. It's important to note that certain individuals, like those with other significant neurological disorders or pregnant women, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Diagnosis of idiopathic PD
• • At least 21 years old
• • Existing or planned 7T brain imaging
• • Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
• • Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)
• Exclusion criteria:
• • Other significant neurological disorder
• • History of dementia
• • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
• • Pregnant women
• • Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip