Nurse Management of Neuromodulation Therapy (DBS)

May 13, 2015 updated by: Christopher Butson, Medical College of Wisconsin

Mobile Computing Platform to Improve Outcomes From Deep Brain Stimulation Therapy

The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision support system for individual patient management will enable considerable time savings compared to standard care. This hypothesis was formulated from pilot studies that showed dramatic decreases in DBS programming time compared to standard care for clinicians who used an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes. Study group Parkinson's patients with DBS Systems

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In most cases these subjects have failed to maintain adequate control of their symptoms on medications alone.

The Diagnosis of PD (Parkinson's Disease) and the decision to have DBS qualifies a subject for enrollment. Subjects would be selected because they will require DBS programming.

The investigators will prospectively enroll 20 PD DBS patients at the Froedtert Movement Disorders Center (surgical targets: subthalamic nucleus (STN) or internal segment of globus pallidus (GPi). Post-operative care, patients will be randomized 1/1 to standard care or using the clinical decision support system. The DBS RN will use ImageVis3D Mobile app on the iPad to program the DBS system, this software does not interact with Froedtert imaging systems. The study team uses identified images provided by the Froedtert PACS system, de identifies them, adds a study code. The images are loaded into the software system and used to identify the leads locations. The Patients will be assessed for 6 months starting with the initial DBS programming session. Importantly, the investigators do not anticipate that the clinical decision support tool will provide the final DBS settings, nor do we anticipate that this approach will obviate the need for motor exams. The clinical decision support system will help nurses choose good initial settings and then explore around those initial settings.

The investigators will measure the time spent on DBS programming for patients in each group. The investigators will capture programming session duration, number of programming sessions and total time spent on DBS programming. The investigators will compare total time spent programming for the standard care versus the intervention group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects 18 and older with a diagnosis of Parkinson's Disease that are scheduled for Deep Brain Stimulation for control of their symptoms and are seen at the Froedtert Neurology Outpatient Clinic.

Exclusion Criteria:

Patient's that are not candidates for Deep Brain Stimulation.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care
DBS using standard of care.
Device: Standard of Care
Patients in the standard of care arm will have their DBS programmed per standard of care which is testing multiple settings and looking for symptom relief through a trial and error process.
Experimental: DBS Clinical Support System
DBS using Clinical Support System.
Device: DBS using Clinical Support System.
The DBS RN (Registered Nurse) will use ImageVis3D Mobile app on the iPad to program the DBS system, this software does not interact with imaging systems. The study team uses identified images provided by the Froedtert PACS system, de identifies them, adds a study code. The images are loaded into the software system and used to identify the leads locations. The Patients will be assessed for 6 months starting with the initial DBS programming session. Importantly, the investigators do not anticipate that the clinical decision support tool will provide the final DBS settings, nor do the investigators anticipate that the approach will obviate the need for motor exams. The clinical decision support system will help nurses choose good initial settings and then explore around those initial settings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure the effectiveness of DBS decision support system in an established clinic.
Time Frame: 6 months

Patients will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS, motor section) by a blinded rater (Dr. Hiner, movement disorders neurologist). Patients will be tested in their best "On" state (e.g.on medication, on stimulation). The investigators will compare UPDRS-III scores for the standard care versus the intervention group. The UPDRS, Motor section is performed at each visit.

Patient-Reported Outcomes

The study team will capture patient-reported QOL (Quality of Life) using PDQ-39 (Parkinson 's Disease Questionnaire. The PDQ-39 is a validated, widely used scale completed by the patient, and is used to assess health-related quality of life in this cohort (Jenkinson, Peto, Fitzpatrick, Greenhall, & Hyman, 1995). Patients will fill out rating scales using a web-based form on an iPad or workstation during each clinic visit.
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Butson, PhD, Medical College of Wiscosnisn

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB_00078062

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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