Parkinson's DiseaseDBSNCT01750242
Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study
An observational study of Parkinson's Disease, run by MedtronicNeuro at 2 sites in United States.
Trial summary
To evaluate DBS device settings and match with the features of the DBS care management software. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Medtronic DBS system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Parkinson's disease patients who have been implanted with the DBS system
Who may be able to join
- Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
- Patient who has had lead placement in the Subthalamic nucleus
- Patient with pre-op MRI available
- Patient with post-op CT scan available showing placement of the lead
- Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off
Who cannot join
- Patient who has had clinically significant persistent stimulation related adverse effects
- Patient who has evidence of lead migration without lead revision
- Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
Kansas City, Kansas, 66160
Scripps Clinic, Division of Neurology
La Jolla, California, 92037
About this study
Official title: OPTIVISE Map Concordance Study in DBS for Parkinson's Disease
To evaluate DBS device settings and match with the features of the DBS care management software.
Read the detailed description
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
- Conditions
- Parkinson's Disease
- Being tested
- Medtronic DBS 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.
Medtronic DBS systemDevice
Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease Subjects | Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN). Receives: Device: Medtronic DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.
Measured: 18 months
Secondary outcomes (1)
Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores
The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.
Measured: Change from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Pahwa, MD, Principal investigator, Parkinson's Disease and Movement Disorder Center, University of Kansas Medical CenterMelissa Houser, MD, Principal investigator, Scripps Clinic Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750242
- Sponsor's protocol ID
- 1669
- Acronym
- DBS
- Status last verified
- May 2024
- First submitted
- 11 Dec 2012
- Last updated
- 3 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIVISE Map Concordance Study in DBS for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01750242
- Acronym / sponsor ID
- DBS / 1669
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate DBS device settings and match with the features of the DBS care management software.
Detailed description
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease Subjects | – | Device: Medtronic DBS systemSubjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients who have been implanted with the DBS system
Key inclusion criteria (5 listed)
- Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
- Patient who has had lead placement in the Subthalamic nucleus
- Patient with pre-op MRI available
- Patient with post-op CT scan available showing placement of the lead
- Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off
Key exclusion criteria (3 listed)
- Patient who has had clinically significant persistent stimulation related adverse effects
- Patient who has evidence of lead migration without lead revision
- Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
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 |
|---|---|---|
| Medtronic DBS systemAdvanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system. | Device | Parkinson's disease Subjects |
Primary outcome
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
Time frame: 18 months
The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.
1 secondary outcome
Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores
Time frame: Change from baseline to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Parkinson Disease
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.
Rajesh Pahwa, MD principal investigator
Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center
Melissa Houser, MD principal investigator
Scripps Clinic Division of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by MedtronicNeuro at 2 sites in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap (time frame: 18 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 3 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.