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

The University of Alabama at Birmingham

Status: Completed

Conditions: Parkinson's Disease

Treatments: Other: DBS stimulator setting alteration; Other: virtual reality simulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01769690

F121004006

1K23NS080912 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 1 patient group

DBS stimulator setting alteration

Experimental group

Treatment:

Other: DBS stimulator setting alteration

Other: virtual reality simulator