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

NCT01769690 | Completed

• 2 other identifiers: F1210040061K23NS080912
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 non-consecutive nights of sleep study within 4 weeks

Secondary Outcomes (1)

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

  4 weeks

Other Outcomes (1)

• Motor outcomes

  4 weeks

Study Arms (1)

DBS stimulator setting alteration

EXPERIMENTAL

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

Interventions

DBS stimulator setting alteration 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

DBS stimulator setting alteration

virtual reality simulator 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.

Also known as: Wake time vigilance in PD patients

DBS stimulator setting alteration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age or older
• Ability to walk up and down stairs

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Amy Amara, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 17, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

US (1)