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 : February 14, 2017
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
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.
- 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).
- 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
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
|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|
|Principal Investigator:||Jose Obeso, MD, PhD||Director at Centro Integral de Neurociencias A.C.|