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Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep).
For this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.
This prospective study will use the Percept sensing tools, collectively referred to as Brainsense, to correlate STN and GPi-LFP activity to sleep stages, characterize sleep events and evaluate the effects of DBS stimulation on sleep quality and sleep events. This study may help identify and validate novel biomarkers to assess sleep quality, REM behavior disorder,sleep fragmentation, and awakenings in patients with Parkinson's Disease, which will support overall DBS' efficacy beyond motor symptoms, and supplement interventions to improve sleep, and potentially also guide more effective DBS programming.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN-DBS Group | Experimental | Participants diagnosed with Parkinson's Disease who have subthalamic nucleus (STN) deep brain stimulation as a primary target for their condition |
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| GPi-DBS Group | Experimental | Participants diagnosed with Parkinson's Disease who have Globus Pallidus internus (GPi) deep brain stimulation as a primary target for their condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysomnography ON stimulation then OFF | Device | Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "ON" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensing & Sleep: Parkinson's Disease Sleep Assessment | A 7 item to rate sleep experience scored 0=unsure, 1=No and 2=Yes. Total range of scores is from 0-14 with a higher score indicating more issues with sleep | Day 1 to Day 14 |
| Motor severity | Motor severity will be assessed by the Movement Disorders Society - Unified Parkinson's Disease Rating Scale - part III. This scale is the gold standard for measuring the severity and progression of PD. Part III entails motor examination which consists of 18 questions that are scored on a 0-4 scale. Higher scores suggest greater severity and progressing disease. | Baseline to Day 14 |
| Epworth Sleepiness Scale (ESS) | The ESS is a short, self-administered survey that asks respondents to rate their likelihood of dozing off in eight different situations on a scale of 0-3. The total score ranges from 0-24, and is used to estimate if the respondent has excessive daytime sleepiness that may require medical attention. A score over 10 is abnormal. Higher scores suggest greater severity of daytime sleepiness. | Baseline to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleni O Vaou, MD | Contact | 210 450 8048 | vaou@uthscsa.edu | |
| Omalys Biggs Rodriguez | Contact | 210-450-7547 | biggsrodrigu@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eleni O Vaou, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Pablo Coss, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio - Brain Health Center | Recruiting | San Antonio | Texas | 78229 | United States |
All de-identified individual participant data will be shared with colleagues and in a peer review journal once analyzed and ready for publication. Summary results will be shared on ClinicalTrials.gov.
Data will be shared once the study is complete and data has been analyzed.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial
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The subject will be randomized after completion of the baseline visit. This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed to the patient only.
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| Polysomnography OFF stimulation then ON | Device | Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "OFF" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control. |
|
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| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |