Parkinson's DiseaseNCT01352819
Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
An observational study of Parkinson's Disease, run by Abbott Medical Devices at 6 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 21 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Libra™/LibraXP™ DBS System Eligible subjects in this study will be screened to confirm that they meet the strict guidelines for advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication followed by surgery to implant the Libra™/LibraXP™ deep brain simulation system.
Who may be able to join
- Subjects enrolled in this study must meet the following inclusion criteria:
- Subject has signed an informed consent.
- Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- Subject is a candidate for surgery.
- Subject is 18 to 80 years of age.
- Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
- Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
- Subject has any condition requiring repeated MRI scans;
- Subject has any condition requiring diathermy;
- Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
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- Subject has a history of cranial surgery.
- Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator.
- Subject abuses drugs or alcohol.
- Subject has a history of seizure
- Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months.
- Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
- Subject has participated in a drug, device or biological trial within the preceding 30 days.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
University Hospital Bonn
Bonn
University Hospital of Duesseldorf
Düsseldorf
University Hospital Regensburg
Regensburg, 93053
About this study
Official title: A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.
Read the detailed description
This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.
A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS motor scores
Comparison of Parkinson's symptoms as demonstrated by the UPDRS motor scores in the medication 'Off' state at Baseline compared to the medication 'Off' with stimulation "On" 3 months after device implantation
Measured: [Time Frame: 3 months after device implantation].
Secondary outcomes (4)
Satisfaction of therapy
Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year
Measured: [through 3, 6 months and 1 year]
Economic burden of the disease
Rate on economic burden of the disease for caregiver determined from economic burden questionnaire at baseline and 1 year
Measured: [at baseline and 1 year]
Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI)
Measured: [at baseline, 3 month and 1 year]
Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver
Measured: [baseline, 3,6 month and 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Vesper, Prof, Principal investigator, Universitätsklinukum Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352819
- Sponsor's protocol ID
- NM-09-036-EU-DB
- Status last verified
- Nov 2022
- First submitted
- 14 Apr 2011
- Last updated
- 9 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication
- ClinicalTrials.gov ID
- NCT01352819
- Acronym / sponsor ID
- NM-09-036-EU-DB
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 May 2011 (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 objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.
Detailed description
This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.
A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Libra™/LibraXP™ DBS System Eligible subjects in this study will be screened to confirm that they meet the strict guidelines for advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication followed by surgery to implant the Libra™/LibraXP™ deep brain simulation system.
Key inclusion criteria (7 listed)
- Subject has signed an informed consent.
- Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- Subject is a candidate for surgery.
- Subject is 18 to 80 years of age.
- Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
Key exclusion criteria (13 listed)
- Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
- Subject has any condition requiring repeated MRI scans;
- Subject has any condition requiring diathermy;
- Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UPDRS motor scores
Time frame: [Time Frame: 3 months after device implantation].
Comparison of Parkinson's symptoms as demonstrated by the UPDRS motor scores in the medication 'Off' state at Baseline compared to the medication 'Off' with stimulation "On" 3 months after device implantation
4 secondary outcomes
Satisfaction of therapy
Time frame: [through 3, 6 months and 1 year]
Economic burden of the disease
Time frame: [at baseline and 1 year]
Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI)
Time frame: [at baseline, 3 month and 1 year]
Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver
Time frame: [baseline, 3,6 month and 1 year]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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.
Jan Vesper, Prof principal investigator
Universitätsklinukum Dusseldorf
6 sites in 3 countries: 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 Abbott Medical Devices at 6 sites in 3 countries.
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 7 inclusion and 13 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, France, Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
UPDRS motor scores (time frame: [Time Frame: 3 months after device implantation].). 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 9 Nov 2022.