Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
NCT ID: NCT02794233
Last Updated: 2018-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2016-07-31
2017-06-30
Brief Summary
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The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PD patients with implanted DBS
Impedance measurements at different time points.
Impedance measurements
Refer to study description
Interventions
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Impedance measurements
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Eligibility Criteria
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Inclusion Criteria
* Must be taking dopamine agonist or levodopa regimen
* Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)
Exclusion Criteria
* 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
25 Years
80 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Leonardo Brito de Almeida, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida, Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Countries
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References
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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.
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.
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.
Fernandez HH. 2015 Update on Parkinson disease. Cleve Clin J Med. 2015 Sep;82(9):563-8. doi: 10.3949/ccjm.82gr.15004.
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.
Pandey S, Sarma N. Deep brain stimulation: current status. Neurol India. 2015 Jan-Feb;63(1):9-18. doi: 10.4103/0028-3886.152623.
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.
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.
Other Identifiers
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IRB201600567
Identifier Type: -
Identifier Source: org_study_id
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