Parkinson's DiseasePhase 1NCT02709148
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)
A Phase 1 study testing Activa PC+S in people with Parkinson's Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Activa PC+S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 31 Jul 2020
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's Disease (PD).
- Age 45-75 years
- UPDRS III motor score (off PD medications) ≥ 25
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
- Cleared to be scanned in a 7 tesla magnet
- Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Who cannot join
- Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
- Evidence of secondary or atypical parkinsonism
- Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
- Previous pallidotomy or DBS surgery
- Women who are currently pregnant or are breast feeding
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- MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
- Any prior intracranial surgery
- Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
- History of seizures
- Immunocompromised
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
- Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS
The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.
Read the detailed description
Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.
- Conditions
- Parkinson's Disease
- Being tested
- Activa PC+S
- Keywords
- Parkinson's 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.
Activa PC+SDevice
DBS
| Study group | Role | What they receive |
|---|---|---|
| chronic brain recording | Experimental | This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Receives: Device: Activa PC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical and sub-cortical brain signals using Activa PC+S
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.
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 posted15 Mar 2016 (estimated)
- Study start20 Jul 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2020
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 University of MinnesotaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerrold Vitek, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709148
- Sponsor's protocol ID
- NEURO-2016-24512
- Status last verified
- Jan 2021
- First submitted
- 1 Mar 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS
- ClinicalTrials.gov ID
- NCT02709148
- Acronym / sponsor ID
- NEURO-2016-24512
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Mar 2016 (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 purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.
Detailed description
Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic brain recording | Experimental | Device: Activa PC+SThis is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic Parkinson's Disease (PD).
- Age 45-75 years
- UPDRS III motor score (off PD medications) ≥ 25
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
Key exclusion criteria (13 listed)
- Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
- Evidence of secondary or atypical parkinsonism
- Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
- Previous pallidotomy or DBS surgery
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 |
|---|---|---|
| Activa PC+SDBS | Device | chronic brain recording |
Primary outcome
Cortical and sub-cortical brain signals using Activa PC+S
Time frame: 12 months
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.
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 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jerrold Vitek, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Activa PC+S in people with Parkinson's Disease, run by University of Minnesota at 1 site 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 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 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?
Cortical and sub-cortical brain signals using Activa PC+S (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 13 Jan 2021.