Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Parkinson Disease Clinical Trial

Official title:

Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05089682
• Other study ID #: 19-001216
• Status: Terminated
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 18, 2021

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Nervous System Diseases
• Neurological Disease
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants to Complete Study	Total number of participants to complete all scheduled study activities	Through study completion, approximately 1 year
Secondary	Total Sleep Time	Length of sleep time reported in minutes	Baseline, post-intervention (approximately 1 night)
Secondary	Psychomotor Vigilance Test	Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes).	Baseline, post-intervention (approximately 1 night)
Secondary	Karolinska Sleepiness Scale	Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep.	Baseline, post-intervention (approximately 1 night)
Secondary	Latency to Sleep Onset	Time in minutes from beginning of study to the first stage of sleep	Baseline, post-intervention (approximately 1 night)
Secondary	Latency to Rapid Eye Movement (REM) Sleep	Time in minutes from beginning of sleep to first REM sleep onset.	Baseline, post-intervention (approximately 1 night)
Secondary	Number of Sleep Cycles	Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep.	Baseline, post-intervention (approximately 1 night)
Secondary	Number of Awakenings Per Night	Total number of awakenings during night	Baseline, post-intervention (approximately 1 night)

External Links

•   Mayo Clinic Clinical Trials