Movement DisordersNCT03884231
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
An observational study of Movement Disorders and Parkinson Disease, run by Abbott Medical Devices at 16 sites in 5 countries.
Trial summary
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Movement Disorders, Parkinson Disease, Essential Tremor
- What is being tested?
- Infinity DBS System with MR Conditional labelling
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 10 Apr 2019to 20 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with the Infinity DBS system with MR Conditional labeling.
Who may be able to join
- Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
- Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
- Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
- Subject is willing and able to comply with study requirements.
Who cannot join
- Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
- Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
- Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
- Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Subject is currently participating in another clinical investigation that may confound the results of this study.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States9 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Wright State University & Premier Health
Fairborn, Ohio, 45324
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Neurosurgery One
Littleton, Colorado, 80122
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Willis-Knighton Medical Center
Shreveport, Louisiana, 71103
Inland Northwest Research
Spokane, Washington, 99202
Banner University Medical Center Tucson Campus
Tucson, Arizona, 85724
Germany3 sites
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, N. RHIN, 40225
Universitatsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, 55131
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, 72076
Sweden2 sites
Universitetsjukhuset I Lund
Lund, Skåne County, 22185
Akademiska sjukhuset
Uppsala, Uppland, 75185
About this study
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.
- Conditions
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia
- Being tested
- Infinity DBS System with MR Conditional labelling
- Keywords
- Infinity DBS system, ABT-CIP-1026, Deep Brain Stimulation, Magnetic resonance imaging
- Medical subject headings
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infinity DBS System with MR Conditional labellingDevice
Patients implanted with the Infinity DBS system with MR Conditional labeling
| Study group | Role | What they receive |
|---|---|---|
| Infinity DBS System with MR Conditional labelling | The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain. Receives: Device: Infinity DBS System with MR Conditional labelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MRI-related Adverse Events
Any adverse event that was included in the primary endpoint analysis, if it:
- Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and
- Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and
- Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.
Measured: From MRI procedure through 1 month post-MRI procedure
Secondary outcomes (5)
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode
Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful MRI mode 'turn on/off' functionality of the MRI mode was assessed.
Measured: Immediately after the MRI scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful 'turn on/off' functionality for the stimulation was assessed.
Measured: Immediately after the MRI scan
Rate of Successful Adjustments to the Stimulation Amplitude
Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful adjustments to the stimulation amplitude was assessed.
Measured: Immediately after the MRI scan
Rate of Successful Interrogation and Download of the IPG Parameters
Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful interrogation and download of the IPG parameters was assessed.
Measured: Immediately after the MRI scan
Rate of Successful Ability to Obtain Lead Impedance Measurements
Secondary endpoints were evaluated after the MRI scan on subjects, who were scanned with a full system configuration. Rate of successful ability to obtain lead impedance measurements was assessed.
Measured: Immediately after the MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start10 Apr 2019
- Primary completion22 Jul 2021
- Study completion20 Aug 2021
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 Movement DisordersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binith Cheeran, Study director, Abbott Medical Devices Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884231
- Sponsor's protocol ID
- ABT-CIP-10262
- Status last verified
- Sep 2024
- First submitted
- 19 Mar 2019
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
- ClinicalTrials.gov ID
- NCT03884231
- Acronym / sponsor ID
- ABT-CIP-10262
- Conditions
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia
- Keywords
- Infinity DBS system, ABT-CIP-1026, Deep Brain Stimulation, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infinity DBS System with MR Conditional labelling | – | Device: Infinity DBS System with MR Conditional labellingThe Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This clinical investigation will enroll subjects with levodopa-responsive Parkinson's disease, primary or secondary dystonia, or disabling tremor, and have been, or will be, implanted with the Infinity DBS system with MR Conditional labeling.
Key inclusion criteria (4 listed)
- Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
- Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
- Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
- Subject is willing and able to comply with study requirements.
Key exclusion criteria (5 listed)
- Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
- Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
- Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
- Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Subject is currently participating in another clinical investigation that may confound the results of this study.
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 |
|---|---|---|
| Infinity DBS System with MR Conditional labellingPatients implanted with the Infinity DBS system with MR Conditional labeling | Device | Infinity DBS System with MR Conditional labelling |
Primary outcome
Rate of MRI-related Adverse Events
Time frame: From MRI procedure through 1 month post-MRI procedure
Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.
5 secondary outcomes
Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode
Time frame: Immediately after the MRI scan
Rate of Successful 'Turn on/Off' Functionality for the Stimulation
Time frame: Immediately after the MRI scan
Rate of Successful Adjustments to the Stimulation Amplitude
Time frame: Immediately after the MRI scan
Rate of Successful Interrogation and Download of the IPG Parameters
Time frame: Immediately after the MRI scan
Rate of Successful Ability to Obtain Lead Impedance Measurements
Time frame: Immediately after the MRI scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Binith Cheeran study director
Abbott Medical Devices Neuromodulation
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Parkinson Disease, run by Abbott Medical Devices at 16 sites in 5 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 4 inclusion and 5 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Sweden, France, Spain. 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 20 Nov 2024). 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?
Rate of MRI-related Adverse Events (time frame: From MRI procedure through 1 month post-MRI procedure). 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 20 Nov 2024.