- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231487
Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders
The purpose of the research is to better understand the motor behavior of individuals in health and disease. The specific purpose of this project is to identify if we can utilize a smartphone to diagnose different movement disorders and monitor their symptoms.
A. Objectives
- Estimate symptom severity of Essential tremor (ET), Parkinson's disease (PD), Huntington's disease (HD), Primary focal dystonia (PFD), spinocerebellar ataxia (SCA), and Functional movement disorders (FMD) using a smartphone-based application
- Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data
- Differentiate individuals with a specific movement disorder from people with other movement disorders based on features from the smartphone data
B. Hypotheses / Research Question(s) We hypothesize that we can estimate the severity of symptoms using a smartphone application and that, using those estimates, we can differentiate individuals with movement disorders from healthy controls and from people with other movement disorders.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jean-François Daneault, PhD
- Phone Number: 973-972-8482
- Email: jf.daneault@rutgers.edu
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07107
- Recruiting
- Rutgers University
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Contact:
- Jean-François Daneault, PhD
- Phone Number: 973-972-8482
- Email: jf.daneault@rutgers.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- People with movement Disorders,
We will recruit 7 parallel groups: 1) ET patients; 2) Healthy controls; 3) PD patients; 4) HD patients; 5) PFD patients; 6) SCA patients; and 7) FMD patients
- Healthy Controls.
Description
Inclusion Criteria:
- Male and female
- At least 18 years of age
- Ambulatory
- English speaking
- Specific to group 1: a) Diagnosis of ET, b) stable dose of medication for 30 days
- Specific to group 3: a) Diagnosis of PD, b) stable dose of medication for 30 days
- Specific to group 4: a) Diagnosis of HD, b) stable dose of medication for 30 days
- Specific to group 5: a) Diagnosis of PFD, b) stable dose of medication for 30 days
- Specific to group 6: a) Diagnosis of SCA, b) stable dose of medication for 30 days
- Specific to group 7: a) Diagnosis of FMD, b) stable dose of medication for 30 days
Exclusion Criteria:
- Serious untreated psychiatric illness that could impact the data collection
- Inability to understand task or protocol due to cognitive problems
- Other neurological condition that could affect the performance of motor tasks
- Musculoskeletal condition that could affect the performance of motor tasks
- Uncorrected vision impairment
- Specific to groups 1, 3, 4, 5, 6, and 7: Expected change in medication within the next 8 weeks
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Essential tremor
This is not an intervention study. Specific to group: a) Diagnosis of ET, b) stable dose of medication for 30 days |
Parkinson's Disease
This is not an intervention study. Specific to group: a) Diagnosis of PD, b) stable dose of medication for 30 days |
Huntington's Disease
This is not an intervention study. Specific to group: a) Diagnosis of HD, b) stable dose of medication for 30 days |
Primary Focal Dystonia
This is not an intervention study. Specific to group: a) Diagnosis of PFD, b) stable dose of medication for 30 days |
Spinocerebellar Ataxia
This is not an intervention study.
Specific to group: a) Diagnosis of SCA, b) stable dose of medication for 30 days
|
Functional Movement Disorder
This is not an intervention study.
Specific to group: a) Diagnosis of FMD, b) stable dose of medication for 30 days
|
Healthy Controls
This is not an intervention study. People with Healthy Controls |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UPDRS-III (Unified Parkinson's Disease Rating Scale)
Time Frame: Will occur right after the consent received from patients during the first lab visit.
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Will occur right after the consent received from patients during the first lab visit.
|
TETRAS-performance (The Essential Tremor Rating Assessment Scale)
Time Frame: Will occur right after the consent received from patients during the first lab visit.
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Head Face Tongue Voice Upper limb Lower limb Spirals Handwriting Dot approximation Standing
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Will occur right after the consent received from patients during the first lab visit.
|
Motor UHDRS for HD (Unified Huntington's Disease Rating Scale: Reliability and Consistency)
Time Frame: Will occur right after the consent received from patients during the first lab visit.
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OCULAR PURSUIT (horizontal and vertical) SACCADE INITIATION (horizontal and vertical) SACCADE VELOCITY (horizontal and vertical) DYSARTHRIA TONGUE PROTRUSION MAXIMAL DYSTONIA (trunk and extremities) MAXIMAL CHOREA (face, mouth, trunk and RETROPULSION PULL TEST FINGER TAPS (right and left) PRONATE/SUPINATE-HANDS (right and left) LURIA RIGIDITY-ARMS (right and left) BRADY KINESIA-BODY GAIT TANDEM WALKING
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Will occur right after the consent received from patients during the first lab visit.
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(UDRS) Unified Dystonia Rating Scale
Time Frame: Will occur right after the consent received from patients during the first lab visit.
|
Eyes and upper face Lower face Jaw and tongue Larynx Neck Shoulder and proximal arm (right and left) Distal arm and hand including elbow Pelvis and proximal leg (right and left) Distal leg and foot including knee Trunk
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Will occur right after the consent received from patients during the first lab visit.
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(BARS) Brief Ataxia Rating Scale
Time Frame: Will occur right after the consent received from patients during the first lab visit.
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To develop a brief ataxia rating scale (BARS) for use by movement disorder specialists and general neurologists.
BARS is valid, reliable, and sufficiently fast and accurate for clinical purposes.
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Will occur right after the consent received from patients during the first lab visit.
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(s-FMDRS) Simplified Functional Movement Disorders Rating Scale
Time Frame: Will occur right after the consent received from patients during the first lab visit.
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The Psychogenic Movement Disorders Rating Scale (PMDRS) has potential as a useful objective assessment in clinical research
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Will occur right after the consent received from patients during the first lab visit.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Parkinson Disease
- Dystonia
- Dystonic Disorders
- Movement Disorders
- Huntington Disease
- Essential Tremor
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- Pro2018002015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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