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Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impedance measurements
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Deep Brain Stimulation, Electric Impedance, Parkinson disease

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic Parkinson's patients with DBS (unilateral or bilateral)
  • Must be taking dopamine agonist or levodopa regimen
  • Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)

Exclusion Criteria:

  • Hoehn and Yahr (H&Y) 4 and above
  • History of DBS revision or lead replacement surgery
  • Current or prior non-Medtronic Activa SC, PC or PC+S IPG
  • Historical information of more than 1 hour delay to "ON" state as average

Sites / Locations

  • University of Florida, Center for Movement Disorders and Neurorestoration

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD patients with implanted DBS

Arm Description

Impedance measurements at different time points.

Outcomes

Primary Outcome Measures

Change in impedance value as it relates to the functional state.
Functional state is defined as either: lying, sitting or walking.
Change in impedance value as it relates to the dopaminergic medication state.
Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the "OFF" state (medication effect is not present) and "ON" state (medication effect noted).

Secondary Outcome Measures

Full Information

First Posted
May 27, 2016
Last Updated
May 9, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02794233
Brief Title
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
Official Title
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists). The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
Detailed Description
Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD. At the patient's follow up visit they will be asked to come to the clinic in the "off medication" state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: "OFF" state, transitioning state, and "ON" state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected. "OFF" state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states. Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the "OFF" state to the "ON" state. Patients will be asked to report at what point they felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or "ON"). "ON" state data collection: The "ON" state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states. Summary of the study protocol: "OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation, Electric Impedance, Parkinson disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD patients with implanted DBS
Arm Type
Experimental
Arm Description
Impedance measurements at different time points.
Intervention Type
Other
Intervention Name(s)
Impedance measurements
Intervention Description
Refer to study description
Primary Outcome Measure Information:
Title
Change in impedance value as it relates to the functional state.
Description
Functional state is defined as either: lying, sitting or walking.
Time Frame
1 hour (for both outcomes)
Title
Change in impedance value as it relates to the dopaminergic medication state.
Description
Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the "OFF" state (medication effect is not present) and "ON" state (medication effect noted).
Time Frame
1 hour (for both outcomes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's patients with DBS (unilateral or bilateral) Must be taking dopamine agonist or levodopa regimen Medtronic Neurostimulator Activa SC, PC or PC+S (IPG) Exclusion Criteria: Hoehn and Yahr (H&Y) 4 and above History of DBS revision or lead replacement surgery Current or prior non-Medtronic Activa SC, PC or PC+S IPG Historical information of more than 1 hour delay to "ON" state as average
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Brito de Almeida, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Center for Movement Disorders and Neurorestoration
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25488260
Citation
Aquino CC, Fox SH. Clinical spectrum of levodopa-induced complications. Mov Disord. 2015 Jan;30(1):80-9. doi: 10.1002/mds.26125. Epub 2014 Dec 8.
Results Reference
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PubMed Identifier
16376143
Citation
Butson CR, Maks CB, McIntyre CC. Sources and effects of electrode impedance during deep brain stimulation. Clin Neurophysiol. 2006 Feb;117(2):447-54. doi: 10.1016/j.clinph.2005.10.007. Epub 2005 Dec 22.
Results Reference
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PubMed Identifier
24756517
Citation
Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
Results Reference
background
PubMed Identifier
26366951
Citation
Fernandez HH. 2015 Update on Parkinson disease. Cleve Clin J Med. 2015 Sep;82(9):563-8. doi: 10.3949/ccjm.82gr.15004.
Results Reference
background
PubMed Identifier
9531455
Citation
Kruk ZL, Cheeta S, Milla J, Muscat R, Williams JE, Willner P. Real time measurement of stimulated dopamine release in the conscious rat using fast cyclic voltammetry: dopamine release is not observed during intracranial self stimulation. J Neurosci Methods. 1998 Jan 31;79(1):9-19. doi: 10.1016/s0165-0270(97)00156-8.
Results Reference
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PubMed Identifier
25751463
Citation
Pandey S, Sarma N. Deep brain stimulation: current status. Neurol India. 2015 Jan-Feb;63(1):9-18. doi: 10.4103/0028-3886.152623.
Results Reference
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PubMed Identifier
26968805
Citation
Picillo M, Lozano AM, Kou N, Munhoz RP, Fasano A. Programming Deep Brain Stimulation for Tremor and Dystonia: The Toronto Western Hospital Algorithms. Brain Stimul. 2016 May-Jun;9(3):438-452. doi: 10.1016/j.brs.2016.02.003. Epub 2016 Feb 12.
Results Reference
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PubMed Identifier
24935985
Citation
Satzer D, Maurer EW, Lanctin D, Guan W, Abosch A. Anatomic correlates of deep brain stimulation electrode impedance. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):398-403. doi: 10.1136/jnnp-2013-307284. Epub 2014 Jun 16.
Results Reference
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Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

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