Parkinson's DiseaseKITENCT02509325
Parkinson's KinetiGraph as Tool for DBS Eligibility Assessment
An observational study of Parkinson's Disease, run by MedtronicNeuro at 2 sites in 2 countries.
Trial summary
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Parkinson's Kinetigraph
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2015to Feb 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is represented by Parkinson's Disease (PD) patients who are referred to the DBS surgical center (clinical site) as potential surgical candidate for DBS or to optimize their PD treatment.
Who may be able to join
- Patients are diagnosed with PD.
- Patients are presented to the clinical sites to evaluate DBS candidacy or optimize their PD treatment eventually with DBS therapy.
- Patients are at least 18 years old.
- Patients are able to provide written data release consent as required by Ethics Committee (EC) institutions or local law and regulations.
Who cannot join
- Patients have restricted movement, e.g. bed bound.
- Patients operate heavy machinery for prolonged periods.
- Patients have serious medical conditions that compromise safety or interfere with mobility in addition to PD (e.g. arthritis and rheumatisms).
- Patients have been already screened by Stimulus or EarlyStimulus questionnaires
- Patients present no response to Levodopa medication or have atypical Parkinsonism.
- Patients have major medical or psychiatric illness other than stable, treated depression or anxiety that may jeopardize the patient's ability to give informed consent, follow study requirements, or that may confound the patient's diagnosis or assessments.
- Patients have major neurological diagnoses other than PD.
- Patients are not capable of following the required clinical instructions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Parkinson's KinetiGraph Data Logger (PKG) as a Tool to Measure Motor Fluctuations and Support the DBS Eligibility Assessment of Parkinson's Disease Patients.
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of PD patients to the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.
As part of the routine clinical practice, PD patients are referred to the DBS surgical center (clinical site) to optimize their PD treatment and potentially receive a DBS therapy, and the Principal Investigator (PI), a DBS specialist, assesses their DBS eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (PI assessment):
Read more
- DBS ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history.
- DBS not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history.
As part of routine clinical practice, the PKG responsible physician will provide the patient with the PKG to be worn for 6 to 10 days.
Based on the Global Kinetics Corporation (GKC) algorithm applied on the data recorded by the PKG, a GKC representative assigned the patients to one of the above mentioned groups: DBS ready or DBS not-ready.
The primary objective is to evaluate whether the GKC algorithm can differentiate DBS ready from DBS not-ready patients as assessed during the visit at the clinical site by the DBS specialist. The primary endpoint is therefore the percentage of agreement between the PI assessment and the GKC assessment (DBS ready or DBS not-ready) about the DBS eligibility of the PD patients.
- Conditions
- Parkinson's Disease
- Being tested
- Parkinson's Kinetigraph
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson's KinetigraphDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of agreement between the PI assessment and the GKC assessment to differentiate the DBS Ready (DS) from the DBS Not-Ready (DNR) group.
The percentage of agreement is the number of patients in the Per Protocol (PP) set for which the GKC assessment is equal to the PI assessment, divided by the total number of patients in the Per Protocol (PP) set and multiplied by 100.
Measured: The PI assessment is performed during the examination of the patient by the DBS specialist on the first day of the study. The GKC assessment is calculated once the PKG is returned and it is based on the time period of 6 days of PKG recordings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509325
- Sponsor's protocol ID
- 1.01.8006
- Acronym
- KITE
- Status last verified
- Jan 2022
- First submitted
- 24 Jul 2015
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
PubMed 25928634
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Parkinson's KinetiGraph Data Logger (PKG) as a Tool to Measure Motor Fluctuations and Support the DBS Eligibility Assessment of Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT02509325
- Acronym / sponsor ID
- KITE / 1.01.8006
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Jul 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.
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of PD patients to the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.
As part of the routine clinical practice, PD patients are referred to the DBS surgical center (clinical site) to optimize their PD treatment and potentially receive a DBS therapy, and the Principal Investigator (PI), a DBS specialist, assesses their DBS eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (PI assessment):
- DBS ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history.
- DBS not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history.
As part of routine clinical practice, the PKG responsible physician will provide the patient with the PKG to be worn for 6 to 10 days.
Based on the Global Kinetics Corporation (GKC) algorithm applied on the data recorded by the PKG, a GKC representative assigned the patients to one of the above mentioned groups: DBS ready or DBS not-ready.
The primary objective is to evaluate whether the GKC algorithm can differentiate DBS ready from DBS not-ready patients as assessed during the visit at the clinical site by the DBS specialist. The primary endpoint is therefore the percentage of agreement between the PI assessment and the GKC assessment (DBS ready or DBS not-ready) about the DBS eligibility of the PD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is represented by Parkinson's Disease (PD) patients who are referred to the DBS surgical center (clinical site) as potential surgical candidate for DBS or to optimize their PD treatment.
Key inclusion criteria (4 listed)
- Patients are diagnosed with PD.
- Patients are presented to the clinical sites to evaluate DBS candidacy or optimize their PD treatment eventually with DBS therapy.
- Patients are at least 18 years old.
- Patients are able to provide written data release consent as required by Ethics Committee (EC) institutions or local law and regulations.
Key exclusion criteria (8 listed)
- Patients have restricted movement, e.g. bed bound.
- Patients operate heavy machinery for prolonged periods.
- Patients have serious medical conditions that compromise safety or interfere with mobility in addition to PD (e.g. arthritis and rheumatisms).
- Patients have been already screened by Stimulus or EarlyStimulus questionnaires
- Patients present no response to Levodopa medication or have atypical Parkinsonism.
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 |
|---|---|---|
| Parkinson's Kinetigraph | Device | – |
Primary outcome
Percentage of agreement between the PI assessment and the GKC assessment to differentiate the DBS Ready (DS) from the DBS Not-Ready (DNR) group.
Time frame: The PI assessment is performed during the examination of the patient by the DBS specialist on the first day of the study. The GKC assessment is calculated once the PKG is returned and it is based on the time period of 6 days of PKG recordings
The percentage of agreement is the number of patients in the Per Protocol (PP) set for which the GKC assessment is equal to the PI assessment, divided by the total number of patients in the Per Protocol (PP) set and multiplied by 100.
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 26 Jan 2022.
- Background: PubMed 25928634Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by MedtronicNeuro at 2 sites in 2 countries.
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 4 inclusion and 8 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. 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?
Percentage of agreement between the PI assessment and the GKC assessment to differentiate the DBS Ready (DS) from the DBS Not-Ready (DNR) group. (time frame: The PI assessment is performed during the examination of the patient by the DBS specialist on the first day of the study. The GKC assessment is calculated once the PKG is returned and it is based on the time period of 6 days of PKG recordings). 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 NCT02509325, which also lists 1 linked publication.
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 26 Jan 2022.