Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders

NCT04231487 | Unknown

• 1 other identifier: Pro2018002015
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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. 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. 2.Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data
3. 3.Differentiate individuals with a specific movement disorder from people with other movement disorders based on features from the smartphone data

Conditions

Essential Tremor; Parkinson Disease; Huntington Disease; Dystonia, Primary; Spinocerebellar Ataxias; Movement Disorders

Outcome Measures

Primary Outcomes (6)

• UPDRS-III (Unified Parkinson's Disease Rating Scale)

  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

  Will occur right after the consent received from patients during the first lab visit.

• TETRAS-performance (The Essential Tremor Rating Assessment Scale)

  Head Face Tongue Voice Upper limb Lower limb Spirals Handwriting Dot approximation Standing

  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)

  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

  Will occur right after the consent received from patients during the first lab visit.

• (UDRS) Unified Dystonia Rating Scale

  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

  Will occur right after the consent received from patients during the first lab visit.

• (BARS) Brief Ataxia Rating Scale

  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.

  Will occur right after the consent received from patients during the first lab visit.

• (s-FMDRS) Simplified Functional Movement Disorders Rating Scale

  The Psychogenic Movement Disorders Rating Scale (PMDRS) has potential as a useful objective assessment in clinical research

  Will occur right after the consent received from patients during the first lab visit.

Study Arms (7)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

Newark, New Jersey, 07107, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease; Huntington Disease; Dystonic Disorders; Spinocerebellar Ataxias; Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Ataxia; Neurologic Manifestations

Central Study Contacts

Jean-François Daneault, PHd

CONTACT

973-972-8482; jf.daneault@rutgers.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 18, 2020
• Study Start: June 27, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)