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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DBS stimulator setting alteration

virtual reality simulator

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring PD, Parkinson's Disease, DBS, deep brain stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for treatment of PD.
Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)
19 years of age or older
Ability to walk up and down stairs

Exclusion Criteria:

Known narcolepsy
Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
Pregnant women will be excluded from this study.
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.
Inability to walk without assistance, including a cane, wheelchair, or walker
Cognitive dysfunction that would prevent subject's ability to participate in the study.
Blindness

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS stimulator setting alteration

Arm Description

Outcomes

Primary Outcome Measures

Differences in sleep efficiency between the high and low frequency nights

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

Wake-time vigilance as measured by a virtual reality street-crossing simulator

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.

Full Information

NCT ID

NCT01769690

First Posted

January 10, 2013

Last Updated

February 5, 2020

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01769690

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

February 2020 (Actual)

Study Completion Date

February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

PD, Parkinson's Disease, DBS, deep brain stimulation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Masking Description

Participant was blinded to the DBS settings during the sleep study but investigator was not; however, the investigator was blinded to the DBS setting during the interpretation of the sleep study.

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBS stimulator setting alteration

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

DBS stimulator setting alteration

Intervention Description

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

Intervention Name(s)

virtual reality simulator

Other Intervention Name(s)

Wake time vigilance in PD patients

Intervention Description

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.

Primary Outcome Measure Information:

Title

Differences in sleep efficiency between the high and low frequency nights

Description

Time Frame

3 non-consecutive nights of sleep study within 4 weeks

Secondary Outcome Measure Information:

Title

Wake-time vigilance as measured by a virtual reality street-crossing simulator

Description

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.

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Motor outcomes

Description

Following each sleep study night, subjects will be evaluated with the Unified Parkinson's Disease Rating Scale part III at their overnight DBS settings and 30 minutes after resuming their conventional, motor effective wake-time settings.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for treatment of PD. Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies. Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) 19 years of age or older Ability to walk up and down stairs Exclusion Criteria: Known narcolepsy Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures. Pregnant women will be excluded from this study. 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. Inability to walk without assistance, including a cane, wheelchair, or walker Cognitive dysfunction that would prevent subject's ability to participate in the study. Blindness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Amara, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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