The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients

Completed · Not applicable

Conditions studied: Parkinson's Disease

In brief

The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.

Key facts

Study ID: NCT01769690
Run by: University of Alabama at Birmingham
People needed: 20
Starts: 2012-12-01
Expected to finish: 2020-02-01
Last updated by the study team: 2020-02-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for treatment of PD.
Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)
19 years of age or older
Ability to walk up and down stairs

You may not qualify if…

Known narcolepsy
Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
Pregnant women will be excluded from this study.
Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with continuous positive airway pressure (CPAP), they can re-start the study.
Inability to walk without assistance, including a cane, wheelchair, or walker
Cognitive dysfunction that would prevent subject's ability to participate in the study.
Blindness

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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