Parkinson's DiseasePhase 1NCT02438033
Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
A Phase 1 study testing Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator in people with Parkinson's Disease, run by Nader Pouratian.
Trial summary
Deep brain stimulation for Parkinson's disease is a well established therapy. Current practice requires tedious adjustment of stimulation settings based on frequent patient assessments. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator
- 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
- Sep 2015to Sep 2017
- Phase
- Phase 1
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chart diagnosis of PD as the principal neurologic diagnosis with evidence of dopamine responsiveness.
- Documented PD duration > 5 years.
- Clinical indications for GPi DBS based on presence of motor fluctuations with troublesome dyskinesias despite best medical therapy.
- Age ≥ 21 years of age.
- Able to give informed consent in accordance with institutional policies and participate in the 1-year follow-up, involving assessments and stimulator adjustments.
- Willingness to have unexpected neurological or psychiatric symptoms shared with study clinicians.
- Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded).
Who cannot join
- Tremor-dominant PD.
- Significant neurocognitive impairment in memory domain suggestive of dementing process (based on MOCA and PD-CRS, described below).
- Age > 75 years.
- History of implant-related infection.
- History of bleeding or immune-compromise.
- Patient living greater than 100 miles from UCLA.
Show all 19Show fewer
- Suicide attempt in the last two years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview).
- Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
- Current significant neurological conditions, including epilepsy, stroke, or history of serious head injury with loss of consciousness.
- Uncontrolled medical condition including cardiovascular problems and diabetes.
- Pregnant or planning to become pregnant
- Uncontrolled chronic pain.
- Preoperative use of warfarin or any blood thinning or antiplatelet agent or any patient with abnormally elevated preoperative coagulation profile (either PTT or PT/INR)..
- Significant abnormality on preoperative structural brain MRI.
- Contraindications to MRIs or the need for recurrent body MRIs.
- High risk for surgery.
- Has cardiac pacemaker/defibrillator, implanted medication pump, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulator.
- Patient has had past cranial neurosurgery.
- Patient unable to discontinue therapeutic diathermy.
About this study
Deep brain stimulation for Parkinson's disease is a well established therapy. Current practice requires tedious adjustment of stimulation settings based on frequent patient assessments. Ultimately, the goal is to develop a system that can program itself using signals that are recorded directly from the brain on a continuous basis. Our previous work has identified abnormal electrical signals in the brain that are targeted for stimulation that can potentially be used to develop a self-programming system. In this study, the investigators will test the safety and utility of a novel adapted device that can not only deliver stimulation to the brain but also record brain signals in a patient that is implanted with a deep brain stimulation system. The purpose of this Phase I study is to understand the safety of the device as well as the relationship between these electrical signals measured from deep within the brain and Parkinson's symptoms and how these signals can be used to guide a self-programmed system. The study will entail implanting this special device (Activa PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms, recorded brain signals, and stimulation patterns during a one year period after implantation. Specifically, the investigators will use the Activa PC+S to record GPi (internal globus pallidus) local field potentials between and during programming visits, allowing the surgeon to better characterize a patient's disease. At the same time, the investigators will evaluate the safety of this new device.
Read the detailed description
The device being tested is the Activa Primary Cell and Sensing (PC+S) system which consists of a deep brain stimulation (DBS) generator, specially adapted extension leads, and DBS leads implanted in the globus pallidus internus (GPi) in patients with Parkinson's disease (PD). The Activa PC+S system differs from currently FDA-approved devices in that it is not only capable of delivering therapeutic stimulation through the DBS leads but also recording electrophysiological signals through the same leads. The goal of this pilot study is to evaluate (1) to assess the specificity and stability of the electrophysiological signals recorded with the Activa PC+S system, (2) how the signals recorded by this system correlate with clinical parameters and non-invasive measures of movement, and (3) and the safety of the PC+S system.
The Medtronic Activa Primary Cell (PC) DBS system has a proven record of safety and reliability through extensive human clinical use over the years1. The potential risks associated with the placement and the use of the device have been thoroughly described in previous human trials and retrospective reports. The PC+S device is based on the currently approved device but with added sensing capabilities. In this protocol, we will evaluate the Activa PC+S system using additional sensing components with stimulation parameters commonly used for the treatment of movement disorder.
This trial will follow a non-randomized design with rigorous and comprehensive follow-ups, as described below.
The study will be conducted at the Ronald Reagan UCLA Medical Center and associated facilities through the combined neurology and neurosurgery movement disorders program, which manages over 1,000 patients with PD. The study will provide close follow-up of patients after DBS surgery by a team involving functional neurosurgeons and neurologists with expertise in clinical care of patients with PD.
Patients will be screened according to the inclusion/exclusion criteria. Each patient will be informed about the study to see if they are interested in participating. After the patient signs the informed consent, they will undergo baseline evaluations, and if they qualify, they will undergo surgery to implant the deep brain stimulation system.
After device implantation, patients will complete comprehensive follow-up as described in the protocol below. The patients will return to the clinic at least monthly for the first 3 months for on and off medication assessments and programming. Primary assessments will be administered monthly for the first 3 months, and then every 3 months up to 12 months post-operatively.
LFPs will be recorded across time (intraoperative, during programming, and chronically), across activity states (with quantitative accelerometer and gyroscope measurements), and across disease states (off and on medication, off and on stimulation) to address the primary research questions proposed.
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. Correlations between LFP biosignals and non-invasive measures and clinical assessment of movement will be performed. In addition, correlation between LFP signals and clinically-defined stimulation parameters will be evaluated.
- Conditions
- Parkinson's Disease
- Being tested
- Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator
- Keywords
- Deep Brain Stimulation, Globus Pallidus, GPi, PC+S
- 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 Activa PC+S Sensing Deep Brain Stimulator GeneratorDevice
Patients undergoing deep brain stimulation for Parkinson's disease based on clinically indicated criteria will have the option to enroll in this study, in which the Activa PC+S generator and corresponding extension leads will be implanted rather than the standard Activa PC system. Patients will be assessed every month for 3 months and then every 3 months after, including off and on medication assessments.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All patients will be implanted with the investigational device in an open-label fashion Receives: Device: Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: 12 months
Secondary outcomes (2)
Change in Hoehn and Yahr Scale
Measured: 12 months
Change in Parkinson's Disease Questionnaire (PDQ-39)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Not approved by CMS
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Pouratian
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Nader Pouratian, University of California, Los Angeles
- Investigators
- Nader Pouratian, MD PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438033
- Sponsor's protocol ID
- PC PC+S
- Status last verified
- Feb 2016
- First submitted
- 28 Apr 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02438033
- Acronym / sponsor ID
- PC PC+S
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation, Globus Pallidus, GPi, PC+S
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved by CMS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nader PouratianUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 May 2015 (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.
Deep brain stimulation for Parkinson's disease is a well established therapy. Current practice requires tedious adjustment of stimulation settings based on frequent patient assessments. Ultimately, the goal is to develop a system that can program itself using signals that are recorded directly from the brain on a continuous basis. Our previous work has identified abnormal electrical signals in the brain that are targeted for stimulation that can potentially be used to develop a self-programming system. In this study, the investigators will test the safety and utility of a novel adapted device that can not only deliver stimulation to the brain but also record brain signals in a patient that is implanted with a deep brain stimulation system. The purpose of this Phase I study is to understand the safety of the device as well as the relationship between these electrical signals measured from deep within the brain and Parkinson's symptoms and how these signals can be used to guide a self-programmed system. The study will entail implanting this special device (Activa PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms, recorded brain signals, and stimulation patterns during a one year period after implantation. Specifically, the investigators will use the Activa PC+S to record GPi (internal globus pallidus) local field potentials between and during programming visits, allowing the surgeon to better characterize a patient's disease. At the same time, the investigators will evaluate the safety of this new device.
Detailed description
The device being tested is the Activa Primary Cell and Sensing (PC+S) system which consists of a deep brain stimulation (DBS) generator, specially adapted extension leads, and DBS leads implanted in the globus pallidus internus (GPi) in patients with Parkinson's disease (PD). The Activa PC+S system differs from currently FDA-approved devices in that it is not only capable of delivering therapeutic stimulation through the DBS leads but also recording electrophysiological signals through the same leads. The goal of this pilot study is to evaluate (1) to assess the specificity and stability of the electrophysiological signals recorded with the Activa PC+S system, (2) how the signals recorded by this system correlate with clinical parameters and non-invasive measures of movement, and (3) and the safety of the PC+S system.
The Medtronic Activa Primary Cell (PC) DBS system has a proven record of safety and reliability through extensive human clinical use over the years1. The potential risks associated with the placement and the use of the device have been thoroughly described in previous human trials and retrospective reports. The PC+S device is based on the currently approved device but with added sensing capabilities. In this protocol, we will evaluate the Activa PC+S system using additional sensing components with stimulation parameters commonly used for the treatment of movement disorder.
This trial will follow a non-randomized design with rigorous and comprehensive follow-ups, as described below.
The study will be conducted at the Ronald Reagan UCLA Medical Center and associated facilities through the combined neurology and neurosurgery movement disorders program, which manages over 1,000 patients with PD. The study will provide close follow-up of patients after DBS surgery by a team involving functional neurosurgeons and neurologists with expertise in clinical care of patients with PD.
Patients will be screened according to the inclusion/exclusion criteria. Each patient will be informed about the study to see if they are interested in participating. After the patient signs the informed consent, they will undergo baseline evaluations, and if they qualify, they will undergo surgery to implant the deep brain stimulation system.
After device implantation, patients will complete comprehensive follow-up as described in the protocol below. The patients will return to the clinic at least monthly for the first 3 months for on and off medication assessments and programming. Primary assessments will be administered monthly for the first 3 months, and then every 3 months up to 12 months post-operatively.
LFPs will be recorded across time (intraoperative, during programming, and chronically), across activity states (with quantitative accelerometer and gyroscope measurements), and across disease states (off and on medication, off and on stimulation) to address the primary research questions proposed.
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. Correlations between LFP biosignals and non-invasive measures and clinical assessment of movement will be performed. In addition, correlation between LFP signals and clinically-defined stimulation parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Medtronic Activa PC+S Sensing Deep Brain Stimulator GeneratorAll patients will be implanted with the investigational device in an open-label fashion |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chart diagnosis of PD as the principal neurologic diagnosis with evidence of dopamine responsiveness.
- Documented PD duration > 5 years.
- Clinical indications for GPi DBS based on presence of motor fluctuations with troublesome dyskinesias despite best medical therapy.
- Age ≥ 21 years of age.
- Able to give informed consent in accordance with institutional policies and participate in the 1-year follow-up, involving assessments and stimulator adjustments.
Key exclusion criteria (19 listed)
- Tremor-dominant PD.
- Significant neurocognitive impairment in memory domain suggestive of dementing process (based on MOCA and PD-CRS, described below).
- Age > 75 years.
- History of implant-related infection.
- History of bleeding or immune-compromise.
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 Activa PC+S Sensing Deep Brain Stimulator GeneratorPatients undergoing deep brain stimulation for Parkinson's disease based on clinically indicated criteria will have the option to enroll in this study, in which the Activa PC+S generator and corresponding extension leads will be implanted rather than the standard Activa PC system. Patients will be assessed every month for 3 months and then every 3 months after, including off and on medication assessments. | Device | Treatment Arm |
Primary outcome
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 12 months
2 secondary outcomes
Change in Hoehn and Yahr Scale
Time frame: 12 months
Change in Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 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 25 Feb 2016.
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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.
Nader Pouratian, MD PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator in people with Parkinson's Disease, run by Nader Pouratian.
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 19 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 25 Feb 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: 12 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 25 Feb 2016.