Parkinson'sDBSNCT02177149
Nurse Management of Neuromodulation Therapy
A study testing DBS using Clinical Support System. in people with Parkinson's, run by Medical College of Wisconsin.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's
- What is being tested?
- DBS using Clinical Support System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient's that are not candidates for Deep Brain Stimulation.
About this study
Official title: 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
Read the 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.
- Conditions
- Parkinson's
- Being tested
- Standard of Care, DBS using Clinical Support System.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareDevice
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.
DBS using Clinical Support System.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | DBS using standard of care. Receives: Device: Standard of Care |
| DBS Clinical Support System | Experimental | DBS using Clinical Support System. Receives: Device: DBS using Clinical Support System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effectiveness of DBS decision support system in an established clinic.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: PI is no longer at MCW, study has been closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson'sStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Butson, Medical College of Wisconsin
- Investigators
- Christopher Butson, PhD, Principal investigator, Medical College of Wiscosnisn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177149
- Sponsor's protocol ID
- IRB_00078062
- Acronym
- DBS
- Status last verified
- May 2015
- First submitted
- 26 Jun 2014
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Computing Platform to Improve Outcomes From Deep Brain Stimulation Therapy
- ClinicalTrials.gov ID
- NCT02177149
- Acronym / sponsor ID
- DBS / IRB_00078062
- Conditions
- Parkinson's
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is no longer at MCW, study has been closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Standard of CareDBS using standard of care. |
| DBS Clinical Support System | Experimental | Device: DBS using Clinical Support System.DBS using Clinical Support System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient's that are not candidates for Deep Brain Stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CarePatients 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. | Device | Standard of Care |
| 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. | Device | DBS Clinical Support System |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Butson, PhD principal investigator
Medical College of Wiscosnisn
Questions about this trial
What is this clinical trial studying?
A study testing DBS using Clinical Support System. in people with Parkinson's, run by Medical College of Wisconsin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the effectiveness of DBS decision support system in an established clinic. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.