Find trials
Consejos para buscar

A Study to Evaluate Manipulating and Optimizing Brain Rhythms to Enhance Sleep

Overview

Información sobre este estudio

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.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Gregory Worrell, M.D., Ph.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

.
CLS-20508796

Mayo Clinic Footer