A Study Evaluating Deep Brain Stimulation for Treating Parkinson's Patients with Insomnia

Overview

About this study

The purpose of this study is to evaluate the safety, and feasibility of adjuvant high frequency stimulation of the GPe using Deep Brain Stimulation.

 

Participation eligibility

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.

Inclusion Criteria:

  • The patient will  be enrolled from the practice of the investigators. 
  • It is anticipated that the single PD patient eligible for this study will range from 40-80 years
  • Patient will have been symptomatic with Parkinsonism for 7-20 years. 
  • The patient must have severe insomnia based on ISI score,

Exclusionary Criteria:

  • Clinically significant dementia (MMSE <23)
  • Hoehn & Yahr [Hoehn, 1967 #1839] stage I or V disease
  • Other significant neurological or psychiatric disease
  • Previous pallidotomy or thalamotomy
  • Previous placement of other implantable devices
  • Secondary parkinsonism (non-idiopathic parkinsonism)
  • Inability to travel to Jacksonville for post-operative study visits
  • Severe sleep apnea
  • Insomnia due to pain or untreated mood disorder
  • Contraindications to 3T MRI
  • Circadian rhythm sleep disorders.
  • Current use of hypnotics

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Pablo Castillo, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Audrey Strongosky C.C.R.C.

(904)953-8308

Strongosky.Audrey2@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20442896

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