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

NCT02522065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-04-04

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Sponsors & Collaborators

  • Massachusetts Institute of Technology

    collaborator OTHER
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • Hospital San Carlos, Madrid

    collaborator OTHER
  • Hospital Universitario Ramon y Cajal

    collaborator OTHER
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER
  • Hospital Universitario Fundación Alcorcón

    collaborator OTHER
  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER
  • Fundación de investigación HM

    lead OTHER

Principal Investigators

  • Jose Obeso, MD, PhD · Director at Centro Integral de Neurociencias A.C.

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522065 on ClinicalTrials.gov