Nighttime recordings of brain signals while changing deep brain stimulation in Parkinson's disease
Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
This project tests whether changing nighttime deep brain stimulation settings and recording brain signals during sleep can help understand and improve sleep in people with Parkinson's disease who have a Medtronic Percept PC implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07110376 on ClinicalTrials.gov |
What this trial studies
This exploratory, prospective, single-center, naturalistic study uses a randomized crossover design to compare different nighttime DBS amplitude settings in people with Parkinson's disease who have bilateral Medtronic Percept PC STN implants. Participants undergo overnight recording of local field potentials (LFPs) and sleep measures while clinicians alternate stimulation amplitudes to capture electrophysiological signatures such as beta-band activity. The goal is to link changes in subcortical beta oscillations with sleep architecture and symptoms to identify biomarkers of the sleep state. Results will inform optimal stimulation parameters for sleep and the potential of LFP-guided adaptive (closed-loop) DBS.
Who should consider this trial
Good fit: Ideal candidates are adults with idiopathic Parkinson's disease who have bilateral Medtronic Percept PC STN implants with stable, optimized settings for at least three months, can ambulate independently, and can provide informed consent.
Not a fit: Patients without the Percept PC device, those with other neurological diseases, untreated significant sleep apnea or active sleep disorders, major cognitive impairment, or who cannot travel to the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could identify stimulation settings or neural biomarkers that lead to better nighttime DBS strategies and improved sleep quality for people with Parkinson's.
How similar studies have performed: Prior DBS studies have demonstrated improvements in sleep and motor function, but applying LFP-guided or adaptive DBS specifically during sleep is a relatively novel approach that has not been tested in large trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Saar Anis, MD
- Email: ANISS2@ccf.org
- Phone: 216 678-8896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.