GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial

NCT02668835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2020-03-18

No results posted yet for this study

Summary

The proposed study will capitalize on the early predictive information stored in an individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features of tremors that can be extracted from movement data gathered by modern compact accelerometers in order to determine if accurate discrimination of essential tremor (ET) from PD can be achieved. Both of these technologies have a proven but somewhat limited ability to inform diagnosis of PD or differentiation of PD from ET - especially at early stages of the disease. The investigators hypothesize that a combination of prior genetic risk and current disease symptomology can synergize for accurate and early discrimination of PD from ET and ultimately inform a cost effective approach to movement disorder diagnosis.

In this study, the investigators will collect blood from individuals with confirmed late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the genetic risk of individuals for PD via proven genetic risk models. In addition, participants will wear a wristwatch-like accelerometer device that will track their movements (tremors) at high temporal resolution and transmit movement data via a smartphone. Cognitive distraction tasks will be administered via mobile phones while simultaneously collecting movement data. Predictive tremor features will be extracted from movement data via signal processing approaches - e.g. discrete wavelet transformation. A final predictive model combining movement tracking information and genetic information will be designed in attempt to distinguish PD from ET individuals.

Conditions

Interventions

DEVICE

Non intervention-Monitoring device

Fox Insight self-monitoring android app and smartwatch Participants will be asked to wear a smartwatch with accelerometers, during day and night, for a period of 2 weeks. Additionally, a self-monitoring app on a smartphone is used, where the participant reports when they take any medication and performs a focused attention task to encourage resting tremor.

GENETIC

Non intervention-Genetic testing

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER
  • Intel Corporation

    collaborator INDUSTRY
  • Scripps Translational Science Institute

    lead OTHER

Principal Investigators

  • Ali Torkamani, PhD · Scripps Translational Science Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-02-28
Completion
2019-04-30

More Related Trials

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 NCT02668835 on ClinicalTrials.gov