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

NCT02522065 | Completed

• 1 other identifier: 15.05.796-GHM
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Parkinson Disease

Keywords

Hypokinesia; Patient Outcome Assessment

Outcome Measures

Primary Outcomes (1)

• 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).

  24-weeks

Secondary Outcomes (5)

• Agreement between nQ and UPDRS motor subscale

  4,8,16,24-weeks

• Comparison between nQ and the different motor tests (Purdue Pegboard test score & Alternating Finger Tapping)

  4,8,16,24-weeks

• Effect of dopaminergic medication measured by nQ

  4,8,16,24-weeks

• Comparison between nQ and the CISI-PD, PDQ-39 and NMSS scales

  4,8,16,24-weeks

• Stability of the nQ index in a less controlled environment ("home-setting").

  Week 1

Study Arms (2)

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Fundación de investigación HM: lead
• Massachusetts Institute of Technology: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital San Carlos, Madrid: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario Fundación Alcorcón: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (6)

Fundacion Hospital Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario HM Puerta del Sur - Centro Integral de Neurociencias A.C.

Móstoles, Madrid, 28938, Spain

Location

Hospital 12 de Octubre

Madrid, Please Select, 28041, Spain

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Obeso, MD, PhD

  Director at Centro Integral de Neurociencias A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

ES (6)