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

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ClinicalTrials.gov Identifier: NCT02668835
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Intel Corporation
Information provided by (Responsible Party):
Scripps Translational Science Institute

Brief 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.


Condition or disease Intervention/treatment
Parkinson Disease Essential Tremor Device: Non intervention-Monitoring device Genetic: Non intervention-Genetic testing

Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial
Study Start Date : November 2015
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1
Idiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of resting tremor.
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
Cohort 2
Essential Tremor with history of resting tremor. Diagnosis made by a movement disorder specialist
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



Primary Outcome Measures :
  1. Comparison of genetic markers between cohorts (Parkinson's disease and Essential Tremor) [ Time Frame: 2 years ]
    The primary outcome of the study is the generation of genomic information that may inform the diagnosis and/or treatment of movement disorders. The endpoint will be derived from the successful implementation of genomic assays, appropriate bioinformatic and statistical analysis of the genomic data generated by those assays. These analyses and report generation activity may be based on comparison of the genomic profile of a patient with data obtained from other such studies or publicly available data in addition to comparison between datasets generated within this study.

  2. Tremor frequency over two week period [ Time Frame: 2 weeks ]
    A primary outcome of the study is the tremor frequency over two week period that may inform the diagnosis and/or treatment of movement disorders. The endpoint will be derived data recorded from a digital wristwatch-like device. These analyses and report generation activity may be based on comparison between datasets generated within this study.


Secondary Outcome Measures :
  1. Comparison of genetic markers to tremor characteristics [ Time Frame: 2 years ]
    Secondary outcomes for this analysis include the identification of genetic characteristics that differentiate individuals with specific tremor characteristics.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population is limited to individuals presenting in Scripps Health clinics with diagnosis of Parkinson's disease or essential tremor.
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of resting tremor, or:
  • Essential Tremor with history of resting tremor. Diagnosis made by a movement disorder specialist.
  • Midstage in disease process for Parkinson's disease with history of resting tremor

Exclusion Criteria:

  • Dementia as defined by a mini-mental state examination cutoff score of 27
  • Atypical Parkinsonism
  • Akinesia/ rigidity Parkinson's Disease
  • Movement Disorders - Stiff-Person syndrome, choreatic disease, dystonia, progressive supranuclear palsy
  • Motor neuron disease - Multiple sclerosis, amyotrophic lateral sclerosis, motor neuritis, progressive bulbar palsy, progressive muscular atrophy, spinal muscular atrophy
  • Significant neurological comorbidities:

    • Stroke
    • Brain cancer or brain metastases
  • History of bone marrow transplant
  • Cerebral palsy and spastic paraplegia

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): NCT02668835


Sponsors and Collaborators
Scripps Translational Science Institute
Michael J. Fox Foundation for Parkinson's Research
Intel Corporation
Investigators
Principal Investigator: Ali Torkamani, PhD Scripps Translational Science Institute

Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02668835     History of Changes
Other Study ID Numbers: IRB-15-6628
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Signs and Symptoms