NCT02794233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 27, 2016

Last Update Submit

May 9, 2018

Conditions

Parkinson Disease

Keywords

Deep Brain StimulationElectric ImpedanceParkinson disease

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

PD patients with implanted DBS

EXPERIMENTAL

Impedance measurements at different time points.

Other: Impedance measurements

Interventions

Impedance measurementsOTHER

Refer to study description

PD patients with implanted DBS

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida, Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

Related 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.

    PMID: 25488260BACKGROUND

  • 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.

    PMID: 16376143BACKGROUND

  • 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.

    PMID: 24756517BACKGROUND

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

    PMID: 26366951BACKGROUND

  • 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.

    PMID: 9531455BACKGROUND

  • Pandey S, Sarma N. Deep brain stimulation: current status. Neurol India. 2015 Jan-Feb;63(1):9-18. doi: 10.4103/0028-3886.152623.

    PMID: 25751463BACKGROUND

  • 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.

    PMID: 26968805BACKGROUND

  • 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.

    PMID: 24935985BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Leonardo Brito de Almeida, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 9, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Locations

US(1)