Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

Parkinson Disease Clinical Trial

Official title:

Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794233
• Other study ID #: IRB201600567
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Impedance measurements
Refer to study description

Locations

Country	Name	City	State
United States	University of Florida, Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View 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. Epub 2005 Dec 22. — View 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. Review. — View Citation

Fernandez HH. 2015 Update on Parkinson disease. Cleve Clin J Med. 2015 Sep;82(9):563-8. doi: 10.3949/ccjm.82gr.15004. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in impedance value as it relates to the functional state.	Functional state is defined as either: lying, sitting or walking.	1 hour (for both outcomes)
Primary	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).	1 hour (for both outcomes)