Nighttime recordings of brain signals while changing deep brain stimulation in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Saar Anis, MD
• Email: ANISS2@ccf.org
• Phone: 216 678-8896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.