Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease

Launched by THE CLEVELAND CLINIC · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different settings of deep brain stimulation (DBS) – a treatment that uses electrical pulses to help control Parkinson’s symptoms – affect brain activity during sleep. The goal is to better understand how changing the DBS settings might impact sleep quality and brain function in people with Parkinson’s disease. This study will take place at a single center and involves trying different stimulation settings in a random order.

To take part, individuals need to be adults (18 or older) diagnosed with Parkinson’s disease who already have a special DBS device implanted in both sides of their brain and have been using it with stable settings for at least three months. Participants should be able to walk on their own, able to give informed consent, and if they take any sleep medications, their doses should be steady for at least a month. People with other neurological conditions, serious untreated sleep problems, dementia, or who work night shifts won’t be eligible. If you join the study, you can expect to have your brain activity monitored while you sleep under different DBS settings to see how these changes might affect your sleep and symptoms. This research aims to improve how DBS is used to support better sleep and overall care for people living with Parkinson’s disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female \> 18 years of age
• • Diagnosed with idiopathic Parkinson Disease
• • Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months
• • Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;
• • Demonstrate ability to ambulate independently;
• • Be capable of providing informed consent;
• • If taking sleep-supporting medications, dosing must be stable for at least 30 days
• Exclusion Criteria:
• • Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
• • Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index\>=15) untreated sleep apnea, uncontrolled restless legs syndrome
• • Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation
• • Ongoing alcohol or substance abuse; Working night shifts or irregular work hours
• • The main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.