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neuroQWERTY: a Transparent Patient-centered Outcome Method to Quantify Parkinsonian Motor Signs for Drug Trials (neuroQWERTY)

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ClinicalTrials.gov Identifier: NCT02522065
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : April 4, 2019
Sponsor:
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
Information provided by (Responsible Party):
Fundación de investigación HM

Brief 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. 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.


Condition or disease
Parkinson Disease

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Motor Response to Dopaminergic Therapy in a Population of de Novo Parkinson's Disease Cases Quantified Via Typing Analyses - -neuroQWERTY
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Agreement between nQ and UPDRS motor subscale [ Time Frame: 4,8,16,24-weeks ]
    Correlation (Spearman Rho) analyses between the indices and UPDRS

  2. Comparison between nQ and the different motor tests (Purdue Pegboard test score & Alternating Finger Tapping) [ Time Frame: 4,8,16,24-weeks ]
    Correlation (Spearman Rho) between the indices and motor test scores

  3. Effect of dopaminergic medication measured by nQ [ Time Frame: 4,8,16,24-weeks ]
    Correlation (Spearman Rho) between the indices and drug titration measured in L-Dopa equivalent milligrams

  4. Comparison between nQ and the CISI-PD, PDQ-39 and NMSS scales [ Time Frame: 4,8,16,24-weeks ]
    Correlation (Spearman Rho) between the indices and the CISI-PD, PDQ-39 and NMSS scales.

  5. Stability of the nQ index in a less controlled environment ("home-setting"). [ Time Frame: Week 1 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Participants between 18 years and 70 years (older subjects will be deemed eligible on an individual basis after review by the study team).
  2. Parkinson's disease (PD) diagnosis according to the United Kingdom Brain Bank Criteria.
  3. PD patients without cognitive or psychiatric disturbances, as measured by the baseline assessment.
  4. 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.
  5. Daily computer use > 30 minutes

Exclusion Criteria:

  1. Mild cognitive impairment or dementia.
  2. Psychiatric symptoms
  3. Expected or current use of sedative medication (benzodiazepines, opiates, antihistaminergic drugs).
  4. Neuroleptic use.
  5. History of parkinsonism for the controls.
  6. Severe osteo-articular problems with upper limb functional limitation (amputations, severe osteo-arthritis).
  7. Alcohol risk use (>40 gr/day or 4 standard drinks for male / >24gr/day or 2 standard drinks for female).
  8. Narcolepsy or other sleep disorder producing hypersomnia (obstructive apnea, acute confusional states).
  9. Any other life- threatening condition (advanced cancer, severe hepatic or renal insufficiencies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522065


Locations
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Spain
Fundacion Hospital Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Universitario HM Puerta del Sur - Centro Integral de Neurociencias A.C.
Mostoles, Madrid, Spain, 28938
Hospital 12 de Octubre
Madrid, Please Select, Spain, 28041
Hospital de La Princesa
Madrid, Spain, 28006
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Fundación de investigación HM
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
Investigators
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Principal Investigator: Jose Obeso, MD, PhD Director at Centro Integral de Neurociencias A.C.
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Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT02522065    
Other Study ID Numbers: 15.05.796-GHM
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by Fundación de investigación HM:
Hypokinesia
Patient Outcome Assessment
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases