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Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231487
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:

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

  1. 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
  2. Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data
  3. 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.


Condition or disease
Essential Tremor Parkinson Disease Huntington Disease Dystonia, Primary Spinocerebellar Ataxias Movement Disorders

Detailed Description:
Movement disorders are a group of neurological conditions that alter human movements. They lead to functional impairments, diminished quality of life, and significant societal, economic, and familial burden. Due to the increase in population and longer life expectancy [1], more and more people will have to live with movement disorders. However, access to movement disorder specialists is already limited and will get worse [2]. Therefore, there is an urgent need to develop tools to aid non-specialist medical professionals identify and manage the symptoms (both motor and non-motor) of those disorders such that specialist can focus on more severe and complex cases. While there are several conditions that can be classified as movement disorders, the current proposal will focus on six disorders that have overlapping symptoms and could prove difficult to differentiate for non-specialists and/or clinicians that do not readily have access to genetic testing or imaging facilities: Essential tremor (ET), Parkinson's disease (PD), Huntington's disease (HD), primary focal dystonia (PFD), spinocerebellar ataxia (SCA), and functional movement disorders (FMD). While trained movement disorder specialists may correctly identify each of these disorders and provide optimal treatment, general practitioners and clinicians living in rural areas that do not have access to the most up-to-date diagnostic tools, such as neuroimaging and genetic testing, may face difficulty when treating those patients due to symptom variability and overlap in symptom presentation between different disorders; leading to sub-optimal treatment outcomes. As such, the development of simple, accurate, and inexpensive tools to help guide their clinical decisions is warranted. The ubiquity of mobile technology and wearable sensors may enable the development of such a tool. In recent years, our group and others have used mobile phones and wearable technology to assess symptoms in a multitude of disorders. This highlights the feasibility of our proposed system for the assessment and monitoring of symptom severity in individuals with movement disorders.

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort
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




Primary Outcome Measures :
  1. UPDRS-III (Unified Parkinson's Disease Rating Scale) [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
    1. Speech (rating 0-4 were 0 is normal and 4 is Unintelligible), similarly following activities are recorded with a scale of (0-4)
    2. Facial Expression
    3. Tremor at Rest (head, upper and lower extremities)
    4. Action or Postural Tremor of Hands
    5. Rigidity (Judged on passive movement of major joints with patient relaxed in sitting position. Cogwheeling to be ignored.)
    6. Finger Taps (Patient taps thumb with index finger in rapid succession.)
    7. Hand Movements (Patient opens and closes hands in rapid succession)
    8. Rapid Alternating Movements of Hands (Pronation-supination movements of hands, vertically and horizontally, with as large an amplitude as possible, both hands simultaneously.)
    9. Leg Agility (Patient taps heel on the ground in rapid succession picking up entire leg. Amplitude should be at least 3 inches.)
    10. Arising from Chair
    11. Posture
    12. Gait
    13. Postural Stability
    14. Body Bradykinesia and Hypokinesia

  2. TETRAS-performance (The Essential Tremor Rating Assessment Scale) [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
    Head Face Tongue Voice Upper limb Lower limb Spirals Handwriting Dot approximation Standing

  3. 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. ]
    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

  4. (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

  5. (BARS) Brief Ataxia Rating Scale [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
    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.

  6. (s-FMDRS) Simplified Functional Movement Disorders Rating Scale [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
    The Psychogenic Movement Disorders Rating Scale (PMDRS) has potential as a useful objective assessment in clinical research



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.

Criteria

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

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): NCT04231487


Contacts
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Contact: Jean-François Daneault, PHd 973-972-8482 jf.daneault@rutgers.edu

Locations
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United States, New Jersey
Rutgers University Recruiting
Newark, New Jersey, United States, 07107
Contact: Jean-François Daneault, PhD    973-972-8482    jf.daneault@rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Responsible Party: Jean-Francois Daneault, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04231487    
Other Study ID Numbers: Pro2018002015
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Dystonic Disorders
Huntington Disease
Essential Tremor
Movement Disorders
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Ataxia
Dyskinesias
Neurologic Manifestations
Dementia
Chorea
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cerebellar Ataxia
Cerebellar Diseases
Spinal Cord Diseases