A Study to Evaluate Manipulating and Optimizing Brain Rhythms to Enhance Sleep
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-001216
About this study
The aim of this feasibility study is to investigate whether we can improve sleep quality in patients who have DBS devices implanted for existing neurological indications by delivering targeted stimulation patterns during specific stages of sleep using their existing DBS device. We will only use electrical stimulation frequencies that have been proven to be safe for patients. We will perform these studies in patients admitted to the hospital in order to examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as brainwave activity, heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to a night of no electrical stimulation.
We hope that our study will open new ways of optimizing sleep in patients with neurological disease who are implanted with DBS device. We also believe tha tour findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
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