Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Mayo Clinic

Status: Terminated

Conditions: Neurological Disease; Epilepsy; Parkinson Disease

Treatments: Device: DBS Stimulation during sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT05089682

19-001216

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Deep Brain Stimulation (DBS) system

Experimental group

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.

Treatment:

Device: DBS Stimulation during sleep