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Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05089682
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
31.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DBS Stimulation during sleep
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Actual Study Start Date :
Apr 12, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment [Through study completion, approximately 1 year]

    Total number of participants to complete all scheduled study activities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Gregory Worrell, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Gregory Worrell, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05089682
Other Study ID Numbers:
  • 19-001216
First Posted:
Oct 22, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Gregory Worrell, Principal Investigator, Mayo Clinic
Deep Brain Stimulation
Additional relevant MeSH terms:
Parkinson Disease
Nervous System Diseases

Study Results

No Results Posted as of Feb 11, 2022