Back to resultsManipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Primary Purpose
Neurological Disease, Parkinson Disease, Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBS Stimulation during sleep
Sponsored by
About this trial
This is an interventional basic science trial for Neurological Disease focused on measuring Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- DBS in one of the defined nuclei of interest during the period of the study
- Male or female, aged 18 years and above
- 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation (DBS) system
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment
Total number of participants to complete all scheduled study activities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05089682
Brief Title
Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Official Title
Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Disease, Parkinson Disease, Epilepsy
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation (DBS) system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DBS Stimulation during sleep
Intervention Description
Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
Primary Outcome Measure Information:
Title
Recruitment
Description
Total number of participants to complete all scheduled study activities
Time Frame
Through study completion, approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DBS in one of the defined nuclei of interest during the period of the study
Male or female, aged 18 years and above
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Worrell, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
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