Parkinson DiseaseNCT01218919
Post Market (Brio™ System) Deep Brain Stimulation (DBS) PD Study
An observational study of Parkinson Disease, run by Abbott Medical Devices.
Trial summary
The objective of this study is to evaluate the effectiveness of a rechargeable 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 Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to 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: Patients with advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication 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
Who may be able to join
- 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 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
- 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 is on anticoagulant medications and is unable to interrupt for time of procedure.
- 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.
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- Subject has a history of seizure (Neurosurgeon must approve)
- 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.
About this study
Official title: A CLINICAL EVALUATION OF A RECHARGEABLE DEEP BRAIN STIMULATION SYSTEM 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 a rechargeable 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.
This is the first observational study for the use of the BRIO™ rechargeable constant current device, using a lead with an active electrode tip for deep brain stimulation in Parkinson subjects. The current study was designed to conform to normal medical practices, taking into consideration the current day economic constraints, while assessing the best set of circumstances for the successful sustained reduction of some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
Read the detailed description
This study is designed as a prospective, observational, non-randomized, multi-centered study for a total of 10 years in duration. It is a 10 year study from system implantation and activation with a yearly database lock and report, with the subjects being used as their own control. The primary outcome assessment will occur at three months. Following completion of the primary outcome assessment, patients will have an annual visit up to 10 years post implant.
Comparison of measures within the same person from pre-treatment to post-treatment will be performed.
During the implantation procedure, each subject will undergo a trial of stimulation in the operating room among other potential assessments to determine proper lead placement. The device may be internalized after a successful intra-operative trial or at a later date according to investigator site practice. The date that all components are implanted and programmed will be classified as "Day 0". After system activation the subject will return to clinic for post-operative evaluations at 1 month (+/-14 days), 3 months (+/-14 days), 6 months (+/-14 days) and 12 months (+/-30 days). Thereafter, a long term data collection program will be followed for 10 years post-implant.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brio 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 bilateral surgery to implant the Brio™ deep brain stimulation system |
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: 3 months after device implantation
Secondary outcomes (5)
PDQ-8
Quality of Life measurements through 3, 6 and 12 months as measured by the PDQ-8 compared to baseline
Measured: 3, 6 and 12 months compared to baseline
modified Schwab and England
Activities of Daily Living measurement through 3, 6 and 12 months as determined from the modified Schwab and England, compared to baseline
Measured: 3, 6 and 12 months compared to baseline
Levodopa dose
Comparison of Levodopa dose taken by the subject at baseline and 3, 6 and 12 month after device implantation
Measured: baseline and 3, 6 and 12 month after device implantation
Satisfaction of therapy
Rate of subject and caregivers therapy satisfaction through 3, 6 and 12 months
Measured: 3, 6 and 12 months
IPG Recharging information
Evaluation of the subjects/caregivers IPG Recharging information
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218919
- Sponsor's protocol ID
- NM-10-017-ID-DB
- Status last verified
- Feb 2019
- First submitted
- 8 Oct 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CLINICAL EVALUATION OF A RECHARGEABLE DEEP BRAIN STIMULATION SYSTEM 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
- NCT01218919
- Acronym / sponsor ID
- NM-10-017-ID-DB
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Oct 2010 (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 a rechargeable 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.
This is the first observational study for the use of the BRIO™ rechargeable constant current device, using a lead with an active electrode tip for deep brain stimulation in Parkinson subjects. The current study was designed to conform to normal medical practices, taking into consideration the current day economic constraints, while assessing the best set of circumstances for the successful sustained reduction of some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
Detailed description
This study is designed as a prospective, observational, non-randomized, multi-centered study for a total of 10 years in duration. It is a 10 year study from system implantation and activation with a yearly database lock and report, with the subjects being used as their own control. The primary outcome assessment will occur at three months. Following completion of the primary outcome assessment, patients will have an annual visit up to 10 years post implant.
Comparison of measures within the same person from pre-treatment to post-treatment will be performed.
During the implantation procedure, each subject will undergo a trial of stimulation in the operating room among other potential assessments to determine proper lead placement. The device may be internalized after a successful intra-operative trial or at a later date according to investigator site practice. The date that all components are implanted and programmed will be classified as "Day 0". After system activation the subject will return to clinic for post-operative evaluations at 1 month (+/-14 days), 3 months (+/-14 days), 6 months (+/-14 days) and 12 months (+/-30 days). Thereafter, a long term data collection program will be followed for 10 years post-implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brio 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 bilateral surgery to implant the Brio™ deep brain stimulation system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication 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
Key inclusion criteria (6 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 UPDRS motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
Key exclusion criteria (10 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 is on anticoagulant medications and is unable to interrupt for time of procedure.
- 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.
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: 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
5 secondary outcomes
PDQ-8
Time frame: 3, 6 and 12 months compared to baseline
modified Schwab and England
Time frame: 3, 6 and 12 months compared to baseline
Levodopa dose
Time frame: baseline and 3, 6 and 12 month after device implantation
Satisfaction of therapy
Time frame: 3, 6 and 12 months
IPG Recharging information
Time frame: 3 and 12 months
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 4 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Abbott Medical Devices.
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 6 inclusion and 10 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 4 Feb 2019. 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?
UPDRS motor scores (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 4 Feb 2019.