Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

NCT05089682 | Terminated Results FDA Device

• 1 other identifier: 19-001216
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Disease; Parkinson Disease; Epilepsy

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Participants to Complete Study

  Total number of participants to complete all scheduled study activities

  Through study completion, approximately 1 year

Secondary Outcomes (7)

• Total Sleep Time

  Baseline, post-intervention (approximately 1 night)

• Psychomotor Vigilance Test

  Baseline, post-intervention (approximately 1 night)

• Karolinska Sleepiness Scale

  Baseline, post-intervention (approximately 1 night)

• Latency to Sleep Onset

  Baseline, post-intervention (approximately 1 night)

• Latency to Rapid Eye Movement (REM) Sleep

  Baseline, post-intervention (approximately 1 night)

Study Arms (1)

Deep Brain Stimulation (DBS) system

EXPERIMENTAL

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

Interventions

DBS Stimulation during sleep 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.

Deep Brain Stimulation (DBS) system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Nervous System Diseases; Parkinson Disease; Epilepsy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

This study was terminated due to inability to enroll subjects due to COVID and complexity of study.

Results Point of Contact

• Title: Dr. Gregory A. Worrell
• Organization: Mayo Clinic

Worrell.Gregory@mayo.edu

507-538-4880

Study Officials

• Gregory Worrell, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 22, 2021
• Study Start: June 22, 2021
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Locations

US (1)