Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2021-12-18

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.

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Detailed Description

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Conditions

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Neurological Disease Parkinson Disease Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation (DBS) system

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.

Group Type EXPERIMENTAL

DBS Stimulation during sleep

Intervention Type DEVICE

Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.

Interventions

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DBS Stimulation during sleep

Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No