Clinical trial NCT01769690: The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients
Official title: The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: PD
Parkinson's Disease
DBS
deep brain stimulation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in sleep efficiency between the high and low frequency nights
timeFrame: 3 non-consecutive nights of sleep study within 4 weeks
Secondary outcomes:
measure: Wake-time vigilance as measured by a virtual reality street-crossing simulator
timeFrame: 4 weeks
Other outcomes:
measure: Motor outcomes
timeFrame: 4 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amy Amara, MD
role: PRINCIPAL_INVESTIGATOR
References: