Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Study Overview
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Brief Summary
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The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.

Official Title
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Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Conditions
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Neurological Disease, Parkinson Disease, Epilepsy

Intervention / Treatment
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* Device: DBS Stimulation during sleep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DBS in one of the defined nuclei of interest during the period of the study Be willing and able to give written and oral informed consent Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence. Exclusion Criteria: Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study. Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate Pregnancy test positive.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation (DBS) system<br>Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device. | Device: DBS Stimulation during sleep<br>* Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants to Complete Study | Total number of participants to complete all scheduled study activities | Through study completion, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Length of sleep time reported in minutes | Baseline, post-intervention (approximately 1 night) | 
| Psychomotor Vigilance Test | Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes). | Baseline, post-intervention (approximately 1 night) | 
| Karolinska Sleepiness Scale | Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep. | Baseline, post-intervention (approximately 1 night) | 
| Latency to Sleep Onset | Time in minutes from beginning of study to the first stage of sleep | Baseline, post-intervention (approximately 1 night) | 
| Latency to Rapid Eye Movement (REM) Sleep | Time in minutes from beginning of sleep to first REM sleep onset. | Baseline, post-intervention (approximately 1 night) | 
| Number of Sleep Cycles | Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. | Baseline, post-intervention (approximately 1 night) | 
| Number of Awakenings Per Night | Total number of awakenings during night | Baseline, post-intervention (approximately 1 night) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation