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

In the proposed study, we will use a within-subject randomized clinical trial to measure
objective changes in sleep architecture with DBS "on" and to compare effects of different DBS
stimulation parameters on sleep architecture as measured by sleep studies. The study design
will allow us to address our hypothesis that low frequency deep brain stimulation parameters
are more effective than the conventional settings at improving sleep architecture and
wake-time vigilance. If our hypothesis is correct, low frequency settings could be used
during sleep and this would prolong stimulator battery life, therefore decreasing the
frequency of required surgical battery changes for DBS. These data will be valuable in
considering clinical treatment strategies and provide insight into the basic mechanisms of
sleep dysfunction in PD. The study may also contribute to understanding how to achieve
maximum clinical benefit from DBS while minimizing morbidity and cost.

Inclusion Criteria:

1. Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for
treatment of PD.

2. Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to
the sleep studies.

3. Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)

4. 19 years of age or older

5. Ability to walk up and down stairs

Exclusion Criteria:

1. Known narcolepsy

2. Other previous surgical treatment of Parkinson's disease(with the exception of
unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.

3. Pregnant women will be excluded from this study.

4. 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.

5. Inability to walk without assistance, including a cane, wheelchair, or walker

6. Cognitive dysfunction that would prevent subject's ability to participate in the
study.

7. Blindness