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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: DBS stimulator setting alteration; Other: virtual reality simulator

• Registration Number: NCT01769690
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-17
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBS stimulator setting alteration	DBS stimulator setting alteration	-
DBS stimulator setting alteration	virtual reality simulator	-

Primary Outcome Measures

Name	Time	Method
Differences in sleep efficiency between the high and low frequency nights	3 non-consecutive nights of sleep study within 4 weeks	Phase I subjects will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." Phase 2 subjects will spend the first night in the sleep lab with DBS turned off. The order of the high and low frequency nights (on the second and third study nights) will be randomized.

Secondary Outcome Measures

Name	Time	Method
Wake-time vigilance as measured by a virtual reality street-crossing simulator	4 weeks	On the morning following the high and low frequency sleep study nights, subjects will evaluated with a virtual reality street-crossing simulator as a measurement of vigilance.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States