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Clinical Trial Summary

This study is aimed at testing the hypothesis that adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Investigators will directly test the efficacy of an adaptive stimulation protocol. Study subjects are adults with Parkinson's disease who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Investigators will implant 20 (n = 10 per clinical site) Parkinson's Disease subjects with the Medtronic RC+S System, enabling the implementation of real-time adaptive stimulation during in-home sleep. Prior to surgery, study subjects will complete clinical sleep questionnaires in an outpatient setting and wear an actigraphy watch for 3 weeks to monitor sleep architecture and sleep fragmentation. Three months after subjects have completed their standard-of-care Deep Brain Stimulation surgery and are optimized in terms of Parkinson's medication and clinical DBS stimulation parameters, we will monitor sleep for an additional 3 weeks, using in-home monitoring. During each week of the in-home monitoring period, subjects will undergo, in a randomized and double-blind fashion, one of three nocturnal stimulation algorithms: Adaptive stimulation, Open-Loop stimulation (standard clinical stimulation therapy) and No stimulation (control). During the 3 weeks of in-home sleep monitoring, we will monitor sleep architecture and sleep fragmentation using an actigraphy watch and subjects will complete a sleep questionnaire. At the end of the 3-week period of sleep-time randomized, blinded stimulation delivery, subjects will return to their standard stimulation therapy.

Clinical Trial Description

In our previous work, we investigated the use of local field potentials (LFP) recorded from STN-DBS electrodes to identify unique spectral patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation and supporting the notion that biomarkers from STN-recorded LFP could be used to identify specific sleep stages. Aim 1 of this study, ID: NCT04620551, characterized the relationship between aberrant STN activity (via LFP) and sleep dysregulation in PD by recording and analyzing three consecutive nights of STN-LFP with concurrent PSG. During the third night we collected sleep recordings as we delivered sub-threshold stimulation, to assess how stimulation affects sleep-stage duration and transitions. These data directly informed the development and optimization of an adaptive stimulation algorithm. The current study will assess the efficacy of the adaptive stimulation algorithm and will test the working hypothesis that modulation of STN during nighttime sleep will normalize sleep behavior by offsetting aberrant signaling in the sleep network. Investigators will use subjective assessments, 3-week actigraphy, and nocturnal PSG, in 20 PD subjects 3 months after DBS implantation, a point at which DBS and medication will have been therapeutically optimized for PD motor symptoms. Investigators will compare chronic open-loop stimulation to adaptive stimulation, and to a no-stimulation control group. All subjects will experience each of the 3 conditions (one condition per week; OFF-Stim, ON-Stim-Adaptive, ON-Stim-Open), however the order in which each subject is assigned to a condition will be randomized while preserving a balanced ratio of group assignments. Investigators will monitor sleep architecture and quality in all groups for 3 weeks prior to DBS surgery, and then at 3 months post-DBS surgery, using in-home actigraphy. Subjects will be blinded with respect to group assignment to mitigate subject bias, which will be set by the Research Host PC when a subject initiates the recording sequence. The rationale for this aim is (1) to validate a therapeutic intervention for the burdensome non-motor symptom of sleep dysfunction in PD, and (2) to fill a critical gap in our understanding of the contribution of STN-DBS to ameliorating sleep-wake disturbances in PD. The acquisition of these data will improve the understanding of the role of basal ganglia, specifically STN, in sleep hemostasis in PD. We expect that STN-DBS will improve sleep-wake parameters in both the PSG and actigraphy recordings but that adaptive stimulation, targeted at sleep-stage biomarkers, will further optimize sleep and alleviate this non-motor burden in PD. Specifically, we predict that adaptive more so than chronic open-loop STN-DBS during sleep will decrease nonconsolidated sleep, reduce the frequency of awakenings, increase the percentage time spent in REM sleep, reduce daytime sleepiness, and increase subjective experience of restfulness and sleep quality. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05070013
Study type Interventional
Source University of Nebraska
Contact Dulce Maroni, PhD
Phone 402.836.9751
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 1, 2021
Completion date June 30, 2025

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