Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

May 9, 2018 updated by: University of Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • University of Florida, Center for Movement Disorders and Neurorestoration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD patients with implanted DBS
Impedance measurements at different time points.
Other: Impedance measurements
Refer to study description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in impedance value as it relates to the functional state.
Time Frame: 1 hour (for both outcomes)
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.
Time Frame: 1 hour (for both outcomes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Leonardo Brito de Almeida, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201600567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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