Parkinson DiseaseneuroQWERTYNCT02522065
neuroQWERTY: a Transparent Patient-centered Outcome Method to Quantify Parkinsonian Motor Signs for Drug Trials
An observational study of Parkinson Disease, run by Fundación de investigación HM at 6 sites in Spain.
Trial summary
The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 60 participants
- Where
- 6 sitesSpain
- Study dates
- May 2015to Dec 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A group of early Parkinson's disease participants who are going to be prescribed dopaminergic agents and a group of healthy volunteers will be recruited at the different collaborating institutions.
Who may be able to join
- Participants between 18 years and 70 years (older subjects will be deemed eligible on an individual basis after review by the study team).
- Parkinson's disease (PD) diagnosis according to the United Kingdom Brain Bank Criteria.
- PD patients without cognitive or psychiatric disturbances, as measured by the baseline assessment.
- Prescription of symptomatic therapy with L-Dopa or dopamine agonists based on functional impairment attributed to PD. This will be based on the participant's physician criteria based on:
- Involvement of the dominant hand and/or upper limbs.
- Employed patients which the disease impairs their ability to work.
- Daily computer use > 30 minutes
Who cannot join
- Mild cognitive impairment or dementia.
- Psychiatric symptoms
- Expected or current use of sedative medication (benzodiazepines, opiates, antihistaminergic drugs).
- Neuroleptic use.
- History of parkinsonism for the controls.
- Severe osteo-articular problems with upper limb functional limitation (amputations, severe osteo-arthritis).
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- Alcohol risk use (>40 gr/day or 4 standard drinks for male / >24gr/day or 2 standard drinks for female).
- Narcolepsy or other sleep disorder producing hypersomnia (obstructive apnea, acute confusional states).
- Any other life- threatening condition (advanced cancer, severe hepatic or renal insufficiencies.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Fundacion Hospital Alcorcón
Alcorcón, Madrid, 28922
Hospital 12 de Octubre
Madrid, Please Select, 28041
Hospital de La Princesa
Madrid, 28006
Hospital Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario HM Puerta del Sur - Centro Integral de Neurociencias A.C.
Móstoles, Madrid, 28938
About this study
Official title: Motor Response to Dopaminergic Therapy in a Population of de Novo Parkinson's Disease Cases Quantified Via Typing Analyses - -neuroQWERTY
The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. The investigators seek to develop an objective assessment of motor deficits by monitoring the participants natural interactions with a keyboard (on a computer or smart device). This approach provides a window to how the brain behaves during typical daily use of these devices, i.e. writing a report, sending an email or any other task performed on a digital device and thus has the potential to be used easily and regularly. (Importantly, the data gathered are non-sensitive and based only on timing information).
PD participants will be recruited during outpatient visits to PD clinics throughout the Madrid metropolitan region. General entry criteria will be those patients who are scheduled to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact on participants' standard clinical management other than by asking the participants to type for 15 minutes at each of the clinic visits, and installing the investigators proprietary software on their home computer. This software will collect keystroke data alone. (None of the actual information about what is being typed will be collected.) The keystroke data collected will be analyzed and compared with standard clinical metrics of therapeutic response, as well as the in-clinic typing data.
- Conditions
- Parkinson Disease
- Keywords
- Hypokinesia, Patient Outcome Assessment
- Medical subject headings
- Parkinson Disease, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | A sample of 30 healthy volunteers will be recruited to compare the typing signal with that of the cases. | |
| Early Parkinson's disease cases | A sample of 30 early PD cases (i.e. less than five years of disease and no axial signs or fluctuations) that are going to be prescribed de novo dopaminergic therapy will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a motor response to medication > 4 UPDRS-III points detected by the developed algorithm (sensitivity to a motor change).
A diagnostic table will be computed with all the study subjects. Those subjects with a clinical relevant response to medication (> 4 points in UPDRS - III) will be considered as true positives. Then, the accuracy of the typing test to detect them will be evaluated. For this purpose, the sensitivity, specificity, predictive values and ROC curve of a classification algorithm based on our nQ index will be computed. This will allow us assessing the validity of the test to identify a motor change. detected by the developed algorithm (sensitivity to a motor change).
Measured: 24-weeks
Secondary outcomes (5)
Agreement between nQ and UPDRS motor subscale
Correlation (Spearman Rho) analyses between the indices and UPDRS
Measured: 4,8,16,24-weeks
Comparison between nQ and the different motor tests (Purdue Pegboard test score & Alternating Finger Tapping)
Correlation (Spearman Rho) between the indices and motor test scores
Measured: 4,8,16,24-weeks
Effect of dopaminergic medication measured by nQ
Correlation (Spearman Rho) between the indices and drug titration measured in L-Dopa equivalent milligrams
Measured: 4,8,16,24-weeks
Comparison between nQ and the CISI-PD, PDQ-39 and NMSS scales
Correlation (Spearman Rho) between the indices and the CISI-PD, PDQ-39 and NMSS scales.
Measured: 4,8,16,24-weeks
Stability of the nQ index in a less controlled environment ("home-setting").
Bland-Altman analyses to evaluate the stability of the indices in different days where the medication was not changed and therefore a change should not be expected
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Hospital Universitario 12 de Octubre, Hospital San Carlos, Madrid, Hospital Universitario Ramon y Cajal, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Fundación Alcorcón, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Jose Obeso, MD, PhD, Principal investigator, Director at Centro Integral de Neurociencias A.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522065
- Sponsor's protocol ID
- 15.05.796-GHM
- Acronym
- neuroQWERTY
- Status last verified
- Apr 2019
- First submitted
- 6 Aug 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Response to Dopaminergic Therapy in a Population of de Novo Parkinson's Disease Cases Quantified Via Typing Analyses - -neuroQWERTY
- ClinicalTrials.gov ID
- NCT02522065
- Acronym / sponsor ID
- neuroQWERTY / 15.05.796-GHM
- Conditions
- Parkinson Disease
- Keywords
- Hypokinesia, Patient Outcome Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Hospital Universitario 12 de Octubre, Hospital San Carlos, Madrid, Hospital Universitario Ramon y Cajal, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Fundación Alcorcón, Michael J. Fox Foundation for Parkinson's Research
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Aug 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 motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. The investigators seek to develop an objective assessment of motor deficits by monitoring the participants natural interactions with a keyboard (on a computer or smart device). This approach provides a window to how the brain behaves during typical daily use of these devices, i.e. writing a report, sending an email or any other task performed on a digital device and thus has the potential to be used easily and regularly. (Importantly, the data gathered are non-sensitive and based only on timing information).
PD participants will be recruited during outpatient visits to PD clinics throughout the Madrid metropolitan region. General entry criteria will be those patients who are scheduled to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact on participants' standard clinical management other than by asking the participants to type for 15 minutes at each of the clinic visits, and installing the investigators proprietary software on their home computer. This software will collect keystroke data alone. (None of the actual information about what is being typed will be collected.) The keystroke data collected will be analyzed and compared with standard clinical metrics of therapeutic response, as well as the in-clinic typing data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –A sample of 30 healthy volunteers will be recruited to compare the typing signal with that of the cases. |
| Early Parkinson's disease cases | – | –A sample of 30 early PD cases (i.e. less than five years of disease and no axial signs or fluctuations) that are going to be prescribed de novo dopaminergic therapy will be recruited. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A group of early Parkinson's disease participants who are going to be prescribed dopaminergic agents and a group of healthy volunteers will be recruited at the different collaborating institutions.
Key inclusion criteria (7 listed)
- Participants between 18 years and 70 years (older subjects will be deemed eligible on an individual basis after review by the study team).
- Parkinson's disease (PD) diagnosis according to the United Kingdom Brain Bank Criteria.
- PD patients without cognitive or psychiatric disturbances, as measured by the baseline assessment.
- Prescription of symptomatic therapy with L-Dopa or dopamine agonists based on functional impairment attributed to PD. This will be based on the participant's physician criteria based on:
- Daily computer use > 30 minutes
Key exclusion criteria (9 listed)
- Mild cognitive impairment or dementia.
- Psychiatric symptoms
- Expected or current use of sedative medication (benzodiazepines, opiates, antihistaminergic drugs).
- Neuroleptic use.
- History of parkinsonism for the controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with a motor response to medication > 4 UPDRS-III points detected by the developed algorithm (sensitivity to a motor change).
Time frame: 24-weeks
A diagnostic table will be computed with all the study subjects. Those subjects with a clinical relevant response to medication (> 4 points in UPDRS - III) will be considered as true positives. Then, the accuracy of the typing test to detect them will be evaluated. For this purpose, the sensitivity, specificity, predictive values and ROC curve of a classification algorithm based on our nQ index will be computed. This will allow us assessing the validity of the test to identify a motor change. detected by the developed algorithm (sensitivity to a motor change).
5 secondary outcomes
Agreement between nQ and UPDRS motor subscale
Time frame: 4,8,16,24-weeks
Comparison between nQ and the different motor tests (Purdue Pegboard test score & Alternating Finger Tapping)
Time frame: 4,8,16,24-weeks
Effect of dopaminergic medication measured by nQ
Time frame: 4,8,16,24-weeks
Comparison between nQ and the CISI-PD, PDQ-39 and NMSS scales
Time frame: 4,8,16,24-weeks
Stability of the nQ index in a less controlled environment ("home-setting").
Time frame: Week 1
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 4 Apr 2019.
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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.
Jose Obeso, MD, PhD principal investigator
Director at Centro Integral de Neurociencias A.C.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Fundación de investigación HM at 6 sites in Spain.
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 9 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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 participants with a motor response to medication > 4 UPDRS-III points detected by the developed algorithm (sensitivity to a motor change). (time frame: 24-weeks). 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 4 Apr 2019.