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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02522065
First Posted: August 13, 2015
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose

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 3 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
Parkinson Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fundación de investigación HM:

Primary Outcome Measures:
  • Response to therapy measured by nQ and the UPDRS-III and PDQ-39 scales [ Time Frame: 8-weeks ]
    Agreement (Bland-Altman plots) between the neuroQWERTY (nQ) indices and the response to medication defined as the change from baseline to 8th-week in the quality of life as assessed by the Parkinson's Disease Questionnaire (PDQ-39) and in the motor response as assessed by the Unified Parkinson's Disease Rating Scale section -III (UPDRS-III).


Secondary Outcome Measures:
  • Response to therapy measured by nQ and CISI-PD scales [ Time Frame: 8-weeks ]
    Agreement (Bland-Altman plots) between the nQ indices and the response to medication defined as the change from baseline to 8th-week in the response to medication as assessed by the Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)

  • Motor change detection by nQ [ Time Frame: 8-weeks ]
    Accuracy (ROC Curve, cutoff selection, internal and external validity analyses) of the nQ indices to detect a minimally significant motor change defined as ≥ 2.5 (Shulman et al.) and 5 (Schrag et al.) points UPDRS-III change

  • Comparison between nQ and the Alternating Finger Tapping test (test of upper limb motor function) [ Time Frame: 8-weeks ]
    Correlation (Spearman Rho) analyses between the indices and the Alternating Finger Tapping score

  • Comparison between nQ and the Purdue Pegboard test score (test of upper limb motor function) [ Time Frame: 8-weeks ]
    Correlation (Spearman Rho) between the indices and the Purdue Pegboard test score

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

  • nQ reproducibility [ Time Frame: 8-weeks ]
    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


Enrollment: 60
Actual Study Start Date: May 2015
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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
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
Principal Investigator: Jose Obeso, MD, PhD Director at Centro Integral de Neurociencias A.C.
  More Information

Additional Information:
Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT02522065     History of Changes
Other Study ID Numbers: 15.05.796-GHM
First Submitted: August 6, 2015
First Posted: August 13, 2015
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Fundación de investigación HM:
Hypokinesia
Patient Outcome Assessment

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases