Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04231487

Collaborator

(none)

210

Enrollment

Location

42.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 27, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

UPDRS-III (Unified Parkinson's Disease Rating Scale) [Will occur right after the consent received from patients during the first lab visit.]
Speech (rating 0-4 were 0 is normal and 4 is Unintelligible), similarly following activities are recorded with a scale of (0-4) Facial Expression Tremor at Rest (head, upper and lower extremities) Action or Postural Tremor of Hands Rigidity (Judged on passive movement of major joints with patient relaxed in sitting position. Cogwheeling to be ignored.) Finger Taps (Patient taps thumb with index finger in rapid succession.) Hand Movements (Patient opens and closes hands in rapid succession) Rapid Alternating Movements of Hands (Pronation-supination movements of hands, vertically and horizontally, with as large an amplitude as possible, both hands simultaneously.) Leg Agility (Patient taps heel on the ground in rapid succession picking up entire leg. Amplitude should be at least 3 inches.) Arising from Chair Posture Gait Postural Stability Body Bradykinesia and Hypokinesia
TETRAS-performance (The Essential Tremor Rating Assessment Scale) [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
Motor UHDRS for HD (Unified Huntington's Disease Rating Scale: Reliability and Consistency) [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
(UDRS) Unified Dystonia Rating Scale [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
(BARS) Brief Ataxia Rating Scale [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.
(s-FMDRS) Simplified Functional Movement Disorders Rating Scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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