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

NCT ID: NCT01769690

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2020-02-29

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

DBS stimulator setting alteration

Group Type: EXPERIMENTAL

DBS stimulator setting alteration

Intervention Type: OTHER

2 sleep study options Phase I: Participants will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." the order of the "off" and "on" nights will be randomized. Although blinding will be attempted, because of the significant motor effects produced with the "on" setting, participants may be able to tell when the DBS is "OFF." In the second phase, the first sleep study night will be with the stimulator "OFF". The order of the "HIGH", and "LOW" frequency nights will be randomized 1:1 and balanced across subjects and will occur on the 2nd and 3rd PSG nights.

Phase II Sleep study evaluation will include three nights of recording: 1) OFF with the stimulator off, 2) HIGH with the stimulator on at the participant's stable and clinically effective settings, and 3) LOW with the stimulator set at a low frequency that uses less energy

virtual reality simulator

Intervention Type: OTHER

This virtual pedestrian environment is a measure of "real-world" street-crossing behavior. This simulation is composed of an elevated platform that simulates a curb at a street-side and 3 monitors (arranged in a semi-circle) on which the subject, while wearing headtracker equipment, views the virtual environment of bidirectional traffic. When the subject deems it is safe to cross the virtual street, he/she steps off the platform/curb, which activates crossing of the street by a cartoon representation of the participant. The speed of street crossing by the cartoon is determined by each individual subject's walking speed, which is measured prior to the test.

Interventions

DBS stimulator setting alteration

2 sleep study options Phase I: Participants will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." the order of the "off" and "on" nights will be randomized. Although blinding will be attempted, because of the significant motor effects produced with the "on" setting, participants may be able to tell when the DBS is "OFF." In the second phase, the first sleep study night will be with the stimulator "OFF". The order of the "HIGH", and "LOW" frequency nights will be randomized 1:1 and balanced across subjects and will occur on the 2nd and 3rd PSG nights.

Phase II Sleep study evaluation will include three nights of recording: 1) OFF with the stimulator off, 2) HIGH with the stimulator on at the participant's stable and clinically effective settings, and 3) LOW with the stimulator set at a low frequency that uses less energy

Intervention Type: OTHER

virtual reality simulator

This virtual pedestrian environment is a measure of "real-world" street-crossing behavior. This simulation is composed of an elevated platform that simulates a curb at a street-side and 3 monitors (arranged in a semi-circle) on which the subject, while wearing headtracker equipment, views the virtual environment of bidirectional traffic. When the subject deems it is safe to cross the virtual street, he/she steps off the platform/curb, which activates crossing of the street by a cartoon representation of the participant. The speed of street crossing by the cartoon is determined by each individual subject's walking speed, which is measured prior to the test.

Intervention Type: OTHER

Other Intervention Names

Wake time vigilance in PD patients

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Amy Amara, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Amara, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

1K23NS080912

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F121004006

Identifier Type: -

Identifier Source: org_study_id