Parkinson's DiseaseNCT02115802
LFP Correlates of Movement Disorders
A study testing Activa PC+S in people with Parkinson's Disease, run by Colorado Neurological Institute at 1 site in United States.
Trial summary
The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy. 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?
- Activa PC+S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants must be undergoing DBS lead placement for Parkinson's Disease that requires them to be awake during microelectrode recording.
- Potential participants have been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist.
- Potential participants must have a Hoehn and Yahr stage >= 2 in the medications OFF state.
- Potential participants must have documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication. Patients with tremor predominant form of PD, quantified as a UPDRS tremor score in any one limb greater than or equal to 3 and UPDRS sum of axial score (speech, posture, gait, balance) less than or equal to 5, who do not reach the 30% threshold, may be included.
- Potential participants must have evidence of complications of medication, e.g., wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication.
- Potential participants must have the ability to understand instructions in English.
- Potential participants are males or females between the ages of 21 and 75.
Who cannot join
- Individuals who are pregnant, breastfeeding, or are capable of becoming pregnant and not using an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives, intrauterine device, abstinence or spermicide and barrier.
- Individuals who have magnetic resonance imaging (MRI) scans demonstrating cortical atrophy out of proportion to age.
- Individuals who have MRI scans showing focal brain lesions that could indicate a nonidiopathic movement disorder.
- Individuals who have major comorbidity increasing the risk of surgery such as prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin.
- Individuals who have had any prior intracranial surgery.
- Individuals who have clinically active depression defined according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and scored on a validated depression assessment scale.
Show all 14Show fewer
- Individuals who have significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
- Individuals who have a history of seizures.
- Individuals who are immunocompromised.
- Individuals who have an active infection.
- Individuals who require diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition.
- Individuals who have an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
- Individuals who, at the discretion of the research team member, lack the cognitive ability to understand the instructions and fully participate in research tasks.
- Unable to understand written and spoken instructions in English. Individuals who carry a concomitant diagnosis that would preclude them from fully participating in the research tasks due to difficulties associated with comprehending instructions, cooperating with research tasks, or otherwise rendering the individuals incapable of participating in the research tasks. Examples could include a visual or hearing impairment preventing the individual from viewing a computer screen or hearing instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorado Neurological Institute
Englewood, Colorado, 80113
Adam O Hebb, MD
About this study
Official title: Local Field Potential Correlates of Motor Behavior and Pathological Signs in Movement Disorders for Development of Closed Loop Stimulation Systems
The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.
Read the detailed description
The Activa PC+S system will be implanted and programmed under the same clinical procedures and standard of care as the Activa PC system. After implantation and standard clinical programming, participants in our research study will be asked to return for additional research visits where the recording sub-circuit of the device will be activated and local field potentials (LFP) will be recorded in the device and transmitted through telemetry to a base station for storage and future analysis. The sensing, or recording, sub-circuit will be disabled, non-invasively, at the end of each research visit to minimize impact to battery life of the device.
- Conditions
- Parkinson's Disease
- Being tested
- Activa 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.
Activa PC+SDevice
Subjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording.
| Study group | Role | What they receive |
|---|---|---|
| Activa PC+S | Experimental | Specific features of LFP recorded from the deep brain nuclei will be examined for possible correlation with different natural behaviors, such as movement, walking, or speech. Receives: Device: Activa PC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech.
The broadband time domain neural signal across all bipolar pairs will be recorded in series while subjects perform structured behavioral tasks.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Neurological Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Medical Center, Medtronic
- Responsible party
- Principal investigator, Adam O Hebb, Colorado Neurological Institute
- Investigators
- Adam O Hebb, MD, Principal investigator, Colorado Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115802
- Sponsor's protocol ID
- Activa PC+S
- Status last verified
- Feb 2016
- First submitted
- 14 Apr 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Field Potential Correlates of Motor Behavior and Pathological Signs in Movement Disorders for Development of Closed Loop Stimulation Systems
- ClinicalTrials.gov ID
- NCT02115802
- Acronym / sponsor ID
- Activa PC+S
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Colorado Neurological InstituteUniversity, hospital or other
- Collaborators
- Swedish Medical Center, Medtronic
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Apr 2014 (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 record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.
Detailed description
The Activa PC+S system will be implanted and programmed under the same clinical procedures and standard of care as the Activa PC system. After implantation and standard clinical programming, participants in our research study will be asked to return for additional research visits where the recording sub-circuit of the device will be activated and local field potentials (LFP) will be recorded in the device and transmitted through telemetry to a base station for storage and future analysis. The sensing, or recording, sub-circuit will be disabled, non-invasively, at the end of each research visit to minimize impact to battery life of the device.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activa PC+S | Experimental | Device: Activa PC+SSpecific features of LFP recorded from the deep brain nuclei will be examined for possible correlation with different natural behaviors, such as movement, walking, or speech. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Potential participants must be undergoing DBS lead placement for Parkinson's Disease that requires them to be awake during microelectrode recording.
- Potential participants have been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist.
- Potential participants must have a Hoehn and Yahr stage >= 2 in the medications OFF state.
- Potential participants must have documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication. Patients with tremor predominant form of PD, quantified as a UPDRS tremor score in any one limb greater than or equal to 3 and UPDRS sum of axial score (speech, posture, gait, balance) less than or equal to 5, who do not reach the 30% threshold, may be included.
- Potential participants must have evidence of complications of medication, e.g., wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication.
Key exclusion criteria (14 listed)
- Individuals who are pregnant, breastfeeding, or are capable of becoming pregnant and not using an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives, intrauterine device, abstinence or spermicide and barrier.
- Individuals who have magnetic resonance imaging (MRI) scans demonstrating cortical atrophy out of proportion to age.
- Individuals who have MRI scans showing focal brain lesions that could indicate a nonidiopathic movement disorder.
- Individuals who have major comorbidity increasing the risk of surgery such as prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin.
- Individuals who have had any prior intracranial 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+SSubjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording. | Device | Activa PC+S |
Primary outcome
Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech.
Time frame: 3 years
The broadband time domain neural signal across all bipolar pairs will be recorded in series while subjects perform structured behavioral tasks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Adam O Hebb, MD principal investigator
Colorado Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa PC+S in people with Parkinson's Disease, run by Colorado Neurological Institute 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 14 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: status not confirmed, as of the sponsor's last update on 23 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Hanrahan, PhD (720-974-4093, shanrahan@thecni.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech. (time frame: 3 years). 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 23 Feb 2016; AzTrials last refreshed its copy on 31 Oct 2026.