Identification of Clinically Relevant Markers of Deep Bra... | NCT02794233

Studies
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

NCT02794233

Sponsor

University of Florida

Status

Completed

Last Update Posted

May 15, 2018Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Impedance measurements

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

May 27, 2016

First Submission Date that Met QC Criteria

Jun 2, 2016

First Posted Date

Jun 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD patients with implanted DBS	Experimental	Impedance measurements at different time points.	Other: Impedance measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impedance measurements	Other	Refer to study description	PD patients with implanted DBS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonardo Brito de Almeida, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida, Center for Movement Disorders and Neurorestoration		Gainesville	Florida	32607	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25488260	Background	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.
16376143	Background	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases