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

NCT ID: NCT07110376

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-22
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed Description

Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or "adaptive DBS" (aDBS). This approach relies on expanding knowledge of basal ganglia electrophysiology and its correlation with motor symptoms. Augmented beta frequency oscillations (13-35 Hz) in local field potentials (LFP) from the basal ganglia is correlated with severity of the motor systems bradykinesia/rigidity and serve as an electrophysiological biomarker for clinical state. Essentially, aDBS aims to modulate stimulation in response to neural state, offering more precise symptom control.

Sleep disturbances are a prevalent symptom in PWP, affecting a vast majority of patients, and serve as a significant non-motor contributor to quality of life. While DBS has demonstrated benefits in enhancing sleep efficiency and architecture, the mechanisms by which this might occur, as well as the optimal stimulation parameters for treating sleep dysfunctions are unknown. Sleep is associated with a dramatic change in subcortical neural activity compared to the wake state, with decreased beta activity, which could serve as a neurophysiological biomarker for the sleep state. Since beta frequencies are a common target for adaptive DBS studies in PD, addressing sleep-induced reductions in beta activity will be crucial for future algorithm development. Incorrectly interpreting sleep as the "medication-on" state may result in an adaptive algorithm providing the patient with non-optimal stimulation amplitudes that may adversely affect sleep.

There is an urgent need to identify the dose-response curve regarding how stimulation affects sleep quality and neurophysiology. Our primary objective is to address this knowledge gap by obtaining a comprehensive understanding of the subcortical neural signatures of sleep, and their correlation with sleep outcomes under different stimulation currents. This will ultimately enable us to establish the control policy for adaptive control of stimulation amplitude (current). Our central hypothesis is that different stimulation currents will elicit distinct effects on sleep subcortical neural signatures and sleep quality.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Evaluate the Impact of Deep Brain Stimulation Settings on Sleep

Participants with Parkinson's disease implanted with a Medtronic Percept™ deep brain stimulation (DBS) system will undergo a 6-week in-home monitoring protocol. Each participant will be exposed to three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design: (1) no stimulation (0% amplitude), (2) reduced stimulation (50% amplitude), and (3) optimal clinical stimulation. Sleep metrics will be collected nightly using the Dreem Headband wearable electroencephalogram (EEG) device. One night of polysomnography will also be conducted to validate the wearable. Subcortical local field potentials (LFPs) from the subthalamic nucleus will be recorded to assess band power and coherence during different stimulation settings and sleep stages. The study aims to evaluate the effect of DBS settings on sleep efficiency, spectral features of neural activity, and their correlation.

Group Type: EXPERIMENTAL

Nighttime Deep Brain Stimulation with Varying Amplitude Settings

Intervention Type: OTHER

Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.

Interventions

Nighttime Deep Brain Stimulation with Varying Amplitude Settings

Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.

Intervention Type: OTHER

Other Intervention Names

Nocturnal DBS Amplitude Modulation; DBS Sleep Modulation Protocol; 0%, 50%, 100% DBS Night Settings

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Parkinson's Disease Association, Inc

OTHER

Sponsor Role: collaborator

Beacon Biosignals

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

James Liao

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Saar Anis, MD

Role: CONTACT

ANISS2@ccf.org

216 678-8896

Facility Contacts

Project Manager

Role: primary

beukemm@ccf.org

216-372-2867

Saar Anis, MD

Role: backup

ANISS2@ccf.org

216 678-8896

Other Identifiers

25-323 DREAMS-PD

Identifier Type: -

Identifier Source: org_study_id