Parkinson DiseaseNCT02794233
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
A study testing Impedance measurements in people with Parkinson Disease, run by University of Florida at 1 site in United States.
Trial summary
The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Impedance measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's patients with DBS (unilateral or bilateral)
- Must be taking dopamine agonist or levodopa regimen
- Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)
Who cannot join
- Hoehn and Yahr (H\&Y) 4 and above
- History of DBS revision or lead replacement surgery
- Current or prior non-Medtronic Activa SC, PC or PC+S IPG
- Historical information of more than 1 hour delay to "ON" state as average
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists).
The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
Read the detailed description
Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD.
At the patient's follow up visit they will be asked to come to the clinic in the "off medication" state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: "OFF" state, transitioning state, and "ON" state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected.
- "OFF" state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states.
- Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the "OFF" state to the "ON" state. Patients will be asked to report at what point they felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or "ON").
- "ON" state data collection: The "ON" state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states.
Summary of the study protocol:
"OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x
- Conditions
- Parkinson Disease
- Being tested
- Impedance measurements
- Keywords
- Deep Brain Stimulation, Electric Impedance, Parkinson 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.
Impedance measurementsOther
Refer to study description
| Study group | Role | What they receive |
|---|---|---|
| PD patients with implanted DBS | Experimental | Impedance measurements at different time points. Receives: Other: Impedance measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in impedance value as it relates to the functional state.
Functional state is defined as either: lying, sitting or walking.
Measured: 1 hour (for both outcomes)
Change in impedance value as it relates to the dopaminergic medication state.
Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the "OFF" state (medication effect is not present) and "ON" state (medication effect noted).
Measured: 1 hour (for both outcomes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo Brito de Almeida, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794233
- Sponsor's protocol ID
- IRB201600567
- Status last verified
- May 2018
- First submitted
- 27 May 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Aquino CC, Fox SH. Clinical spectrum of levodopa-induced complications. Mov Disord. 2015 Jan;30(1):80-9. doi: 10.1002/mds.26125. Epub 2014 Dec 8.
PubMed 25488260Butson CR, Maks CB, McIntyre CC. Sources and effects of electrode impedance during deep brain stimulation. Clin Neurophysiol. 2006 Feb;117(2):447-54. doi: 10.1016/j.clinph.2005.10.007. Epub 2005 Dec 22.
PubMed 16376143Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
PubMed 24756517Fernandez HH. 2015 Update on Parkinson disease. Cleve Clin J Med. 2015 Sep;82(9):563-8. doi: 10.3949/ccjm.82gr.15004.
PubMed 26366951Kruk ZL, Cheeta S, Milla J, Muscat R, Williams JE, Willner P. Real time measurement of stimulated dopamine release in the conscious rat using fast cyclic voltammetry: dopamine release is not observed during intracranial self stimulation. J Neurosci Methods. 1998 Jan 31;79(1):9-19. doi: 10.1016/s0165-0270(97)00156-8.
PubMed 9531455Pandey S, Sarma N. Deep brain stimulation: current status. Neurol India. 2015 Jan-Feb;63(1):9-18. doi: 10.4103/0028-3886.152623.
PubMed 25751463Picillo M, Lozano AM, Kou N, Munhoz RP, Fasano A. Programming Deep Brain Stimulation for Tremor and Dystonia: The Toronto Western Hospital Algorithms. Brain Stimul. 2016 May-Jun;9(3):438-452. doi: 10.1016/j.brs.2016.02.003. Epub 2016 Feb 12.
PubMed 26968805Satzer D, Maurer EW, Lanctin D, Guan W, Abosch A. Anatomic correlates of deep brain stimulation electrode impedance. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):398-403. doi: 10.1136/jnnp-2013-307284. Epub 2014 Jun 16.
PubMed 24935985
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
- ClinicalTrials.gov ID
- NCT02794233
- Acronym / sponsor ID
- IRB201600567
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Electric Impedance, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Jun 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 study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists).
The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
Detailed description
Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD.
At the patient's follow up visit they will be asked to come to the clinic in the "off medication" state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: "OFF" state, transitioning state, and "ON" state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected.
- "OFF" state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states.
- Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the "OFF" state to the "ON" state. Patients will be asked to report at what point they felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or "ON").
- "ON" state data collection: The "ON" state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states.
Summary of the study protocol:
"OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients with implanted DBS | Experimental | Other: Impedance measurementsImpedance measurements at different time points. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's patients with DBS (unilateral or bilateral)
- Must be taking dopamine agonist or levodopa regimen
- Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)
Key exclusion criteria (4 listed)
- Hoehn and Yahr (H\&Y) 4 and above
- History of DBS revision or lead replacement surgery
- Current or prior non-Medtronic Activa SC, PC or PC+S IPG
- Historical information of more than 1 hour delay to "ON" state as average
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 |
|---|---|---|
| Impedance measurementsRefer to study description | Other | PD patients with implanted DBS |
Primary outcome
Change in impedance value as it relates to the functional state.
Time frame: 1 hour (for both outcomes)
Functional state is defined as either: lying, sitting or walking.
Change in impedance value as it relates to the dopaminergic medication state.
Time frame: 1 hour (for both outcomes)
Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the "OFF" state (medication effect is not present) and "ON" state (medication effect noted).
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 15 May 2018.
- Background: PubMed 25488260Aquino CC, Fox SH. Clinical spectrum of levodopa-induced complications. Mov Disord. 2015 Jan;30(1):80-9. doi: 10.1002/mds.26125. Epub 2014 Dec 8.
- Background: PubMed 16376143Butson CR, Maks CB, McIntyre CC. Sources and effects of electrode impedance during deep brain stimulation. Clin Neurophysiol. 2006 Feb;117(2):447-54. doi: 10.1016/j.clinph.2005.10.007. Epub 2005 Dec 22.
- Background: PubMed 24756517Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
- Background: PubMed 26366951Fernandez HH. 2015 Update on Parkinson disease. Cleve Clin J Med. 2015 Sep;82(9):563-8. doi: 10.3949/ccjm.82gr.15004.
- Background: PubMed 9531455Kruk ZL, Cheeta S, Milla J, Muscat R, Williams JE, Willner P. Real time measurement of stimulated dopamine release in the conscious rat using fast cyclic voltammetry: dopamine release is not observed during intracranial self stimulation. J Neurosci Methods. 1998 Jan 31;79(1):9-19. doi: 10.1016/s0165-0270(97)00156-8.
- Background: PubMed 25751463Pandey S, Sarma N. Deep brain stimulation: current status. Neurol India. 2015 Jan-Feb;63(1):9-18. doi: 10.4103/0028-3886.152623.
- Background: PubMed 26968805Picillo M, Lozano AM, Kou N, Munhoz RP, Fasano A. Programming Deep Brain Stimulation for Tremor and Dystonia: The Toronto Western Hospital Algorithms. Brain Stimul. 2016 May-Jun;9(3):438-452. doi: 10.1016/j.brs.2016.02.003. Epub 2016 Feb 12.
- Background: PubMed 24935985Satzer D, Maurer EW, Lanctin D, Guan W, Abosch A. Anatomic correlates of deep brain stimulation electrode impedance. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):398-403. doi: 10.1136/jnnp-2013-307284. Epub 2014 Jun 16.
- Individual participant dataSharing planned: Yes
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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.
Leonardo Brito de Almeida, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impedance measurements in people with Parkinson Disease, run by University of Florida 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 3 inclusion and 4 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 15 May 2018. 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 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?
Change in impedance value as it relates to the functional state. (time frame: 1 hour (for both outcomes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794233, which also lists 8 linked publications.
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 15 May 2018.