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

Recruiting · NCT07110376 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic

Interventions studied

Nighttime Deep Brain Stimulation with Varying Amplitude Settings

This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

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.

1 location listed across 1 US state.