Parkinson DiseaseNCT04011449
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
A study testing Medtronic RC+S DBS system in people with Parkinson Disease and Parkinson, run by University of Minnesota at 1 site in United States.
Trial summary
Primary objectives. The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize: 1. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease, Parkinson
- What is being tested?
- Medtronic RC+S DBS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- 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 PD.
- Age 45-75 years
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
- 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., major 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 MR imaging (e.g., due to incompatible implanted pacemaker)
- Previous pallidotomy or DBS surgery
- Women who are currently pregnant
Show all 12Show fewer
- MRI brain abnormalities that could indicate a neurological disorder other than idiopathic Lewy body Parkinson's disease.
- Subjects with severe or poorly controlled depression defined according to DSM-V criteria and a scored on a validated depression assessment scale.
- Epilepsy
- 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
Primary objectives.
The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize:
Read more
- The state- and target-dependency of neuronal oscillations in the subthalamic nucleus (STN), internal globus pallidus (GPi) or external globus pallidus (GPe) of patients with PD,
- How these oscillations are altered by levodopa,
- The effects of unilateral standard clinical isochronal (e.g. 140 Hz) GPi-, GPe-, and STN-DBS on oscillatory activity and its relationship to the presence and severity of parkinsonian motor signs.
These experiments will leverage the capacity to record LFPs from macroelectrodes implanted in either the GPi/GPe or STN using the Medtronic RC+S DBS system. The long-term goal for this project is to develop closed-loop methods for DBS that are state (resting vs. movement) and movement-phase appropriate.
Secondary objectives.
In addition to establishing the relationship between neural oscillations in the STN, GPi and GPe to clinical and quantitative measures of akinesia, bradykinesia, tremor and rigidity, this project will also examine the relationship of neural oscillations to:
- Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
- Response inhibition and impulse control.
Read the detailed description
The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of local field potential (LFP) activity from the implanted DBS lead.
LFPs are composite electrical signals generated by the brain. They are conventionally divided into frequency bands, as follows: 0-3 Hz (delta), 4-7 Hz (theta), 8-12 Hz (alpha), 13-30 Hz (beta), 31-200 Hz (gamma), and >200 Hz (high frequency). The instantaneous amplitude and power of the LFP recordings are believed to represent the degree of synchronization among neurons surrounding the electrode. A transient increase in power in a particular band, in response to a behavioral event, is called an event-related synchronization (ERS), while a transient decrease in power is called event-related desynchronization (ERD). ERD and ERS are typically calculated by averaging the power across time segments and comparing this average to a reference epoch.
Research staff at the University of Minnesota will follow FDA guidelines for software development for the RC+S.
- Conditions
- Parkinson Disease, Parkinson
- Being tested
- Medtronic RC+S DBS system
- 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 RC+S DBS systemDevice
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
| Study group | Role | What they receive |
|---|---|---|
| Device Implantation | Experimental | Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system Receives: Device: Medtronic RC+S DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive and Active Rigidity Quantification
Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)
Measured: 6-months
Ballistic Elbow Flexion to a Target: Peak Velocity
Peak velocity
Measured: 6-months
Ballistic Elbow Flexion to a Target: Stop Reaction Time
Stop reaction time
Measured: 6-months
Rapid Alternating Pronation-Supination Movements: RMS
Root Mean Square (RMS)-Displacement RMS
Measured: 6-months
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration
Duration of hesitation or arrest (freezing) episodes
Measured: 6-months
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number
Number of hesitation or arrest (freezing) episodes
Measured: 6-months
Gait: Step length
Step length
Measured: 6-months
Gait: Step Time
Step time
Measured: 6-months
Gait: Double Support Time
Double support time
Measured: 6-months
Gait: Obstacles
Percentage of obstacles successfully avoided
Measured: 6-months
Gait: Freezing Episodes Duration
Duration of freezing episodes
Measured: 6-months
Gait: Freezing Episodes Number
Number of freezing episodes
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Lack of recruitment
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011449
- Sponsor's protocol ID
- NEUR-2019-27724
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2019
- Last updated
- 9 Apr 2021
- Results posted
- No
- 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 9 Apr 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 Using the Medtronic RC+S
- ClinicalTrials.gov ID
- NCT04011449
- Acronym / sponsor ID
- NEUR-2019-27724
- Conditions
- Parkinson Disease, Parkinson
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- 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.
Primary objectives.
The ability of the RC+S to record Local Field Potentials (LFP's) is novel in Deep Brain Stimulation (DBS) technology. The primary goals of this project are to use this function of the RC+S to characterize:
- The state- and target-dependency of neuronal oscillations in the subthalamic nucleus (STN), internal globus pallidus (GPi) or external globus pallidus (GPe) of patients with PD,
- How these oscillations are altered by levodopa,
- The effects of unilateral standard clinical isochronal (e.g. 140 Hz) GPi-, GPe-, and STN-DBS on oscillatory activity and its relationship to the presence and severity of parkinsonian motor signs.
These experiments will leverage the capacity to record LFPs from macroelectrodes implanted in either the GPi/GPe or STN using the Medtronic RC+S DBS system. The long-term goal for this project is to develop closed-loop methods for DBS that are state (resting vs. movement) and movement-phase appropriate.
Secondary objectives.
In addition to establishing the relationship between neural oscillations in the STN, GPi and GPe to clinical and quantitative measures of akinesia, bradykinesia, tremor and rigidity, this project will also examine the relationship of neural oscillations to:
- Levodopa-resistant motor features such as postural instability and gait (including freezing of gait),
- Response inhibition and impulse control.
Detailed description
The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of local field potential (LFP) activity from the implanted DBS lead.
LFPs are composite electrical signals generated by the brain. They are conventionally divided into frequency bands, as follows: 0-3 Hz (delta), 4-7 Hz (theta), 8-12 Hz (alpha), 13-30 Hz (beta), 31-200 Hz (gamma), and >200 Hz (high frequency). The instantaneous amplitude and power of the LFP recordings are believed to represent the degree of synchronization among neurons surrounding the electrode. A transient increase in power in a particular band, in response to a behavioral event, is called an event-related synchronization (ERS), while a transient decrease in power is called event-related desynchronization (ERD). ERD and ERS are typically calculated by averaging the power across time segments and comparing this average to a reference epoch.
Research staff at the University of Minnesota will follow FDA guidelines for software development for the RC+S.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Implantation | Experimental | Device: Medtronic RC+S DBS systemImplantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic PD.
- Age 45-75 years
- Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
- Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
- Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process
Key exclusion criteria (12 listed)
- Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., major 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 MR 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 |
|---|---|---|
| Medtronic RC+S DBS systemImplantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system | Device | Device Implantation |
Primary outcome
Passive and Active Rigidity Quantification
Time frame: 6-months
Peak resistive torque integral of resistive torque over the pronation and supination Range of Motion (ROM)
Ballistic Elbow Flexion to a Target: Peak Velocity
Time frame: 6-months
Peak velocity
Ballistic Elbow Flexion to a Target: Stop Reaction Time
Time frame: 6-months
Stop reaction time
Rapid Alternating Pronation-Supination Movements: RMS
Time frame: 6-months
Root Mean Square (RMS)-Displacement RMS
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Duration
Time frame: 6-months
Duration of hesitation or arrest (freezing) episodes
Rapid Alternating Pronation-Supination Movements: Freezing Episodes Number
Time frame: 6-months
Number of hesitation or arrest (freezing) episodes
Gait: Step length
Time frame: 6-months
Step length
Gait: Step Time
Time frame: 6-months
Step time
Gait: Double Support Time
Time frame: 6-months
Double support time
Gait: Obstacles
Time frame: 6-months
Percentage of obstacles successfully avoided
Gait: Freezing Episodes Duration
Time frame: 6-months
Duration of freezing episodes
Gait: Freezing Episodes Number
Time frame: 6-months
Number of freezing episodes
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 9 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic RC+S DBS system in people with Parkinson Disease and Parkinson, 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 5 inclusion and 12 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 9 Apr 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.
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?
Passive and Active Rigidity Quantification (time frame: 6-months). The study lists 12 primary outcomes in all. 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 Apr 2021.