Parkinson DiseaseGADGET-PDNCT02668835
GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial
An observational study of Parkinson Disease and Essential Tremor, run by Scripps Translational Science Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- What is being tested?
- Non intervention-Monitoring device and Non intervention-Genetic testing
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is limited to individuals presenting in Scripps Health clinics with diagnosis of Parkinson's disease or essential tremor.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- Stroke
- Brain cancer or brain metastases
- History of bone marrow transplant
- Cerebral palsy and spastic paraplegia
About this study
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
- Parkinson Disease, Essential Tremor
- Being tested
- Non intervention-Monitoring device, Non intervention-Genetic testing
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non intervention-Monitoring deviceDevice
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.
Non intervention-Genetic testingGenetic
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Idiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of resting tremor. Receives: Device: Non intervention-Monitoring device; Genetic: Non intervention-Genetic testing | |
| Cohort 2 | Essential Tremor with history of resting tremor. Diagnosis made by a movement disorder specialist Receives: Device: Non intervention-Monitoring device; Genetic: Non intervention-Genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of genetic markers between cohorts (Parkinson's disease and Essential Tremor)
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.
Measured: 2 years
Tremor frequency over two week period
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.
Measured: 2 weeks
Secondary outcomes (1)
Comparison of genetic markers to tremor characteristics
Secondary outcomes for this analysis include the identification of genetic characteristics that differentiate individuals with specific tremor characteristics.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Intel Corporation
- Responsible party
- Sponsor
- Investigators
- Ali Torkamani, PhD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668835
- Sponsor's protocol ID
- IRB-15-6628
- Acronym
- GADGET-PD
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial
- ClinicalTrials.gov ID
- NCT02668835
- Acronym / sponsor ID
- GADGET-PD / IRB-15-6628
- Conditions
- Parkinson Disease, Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Intel Corporation
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Non intervention-Monitoring device, Genetic: Non intervention-Genetic testingIdiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of resting tremor. |
| Cohort 2 | – | Device: Non intervention-Monitoring device, Genetic: Non intervention-Genetic testingEssential Tremor with history of resting tremor. Diagnosis made by a movement disorder specialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is limited to individuals presenting in Scripps Health clinics with diagnosis of Parkinson's disease or essential tremor.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non intervention-Monitoring deviceFox 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. | Device | Cohort 1, Cohort 2 |
| Non intervention-Genetic testing | Genetic | Cohort 1, Cohort 2 |
Primary outcome
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.
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.
1 secondary outcome
Comparison of genetic markers to tremor characteristics
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Torkamani, PhD principal investigator
Scripps Translational Science Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Scripps Translational Science Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of genetic markers between cohorts (Parkinson's disease and Essential Tremor) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.