Essential TremorNCT04231487
Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders
An observational study of Essential Tremor and Parkinson Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor, Parkinson Disease, Huntington Disease
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 31 Dec 2022
- 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 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
Newark, New Jersey, 07107
Jean-François Daneault, PhD, 973-972-8482, jf.daneault@rutgers.edu
About this study
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.
Read the 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.
- Conditions
- Essential Tremor, Parkinson Disease, Huntington Disease, Dystonia, Primary, Spinocerebellar Ataxias, Movement Disorders
- Medical subject headings
- Essential Tremor, Parkinson Disease, Huntington Disease, Dystonic Disorders, Spinocerebellar Ataxias, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
UPDRS-III (Unified Parkinson's Disease Rating Scale)
- 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Will occur right after the consent received from patients during the first lab visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start27 Jun 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231487
- Sponsor's protocol ID
- Pro2018002015
- Status last verified
- Sep 2022
- First submitted
- 7 Jan 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders
- ClinicalTrials.gov ID
- NCT04231487
- Acronym / sponsor ID
- Pro2018002015
- Conditions
- Essential Tremor, Parkinson Disease, Huntington Disease, Dystonia, Primary, Spinocerebellar Ataxias, Movement Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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 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.
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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
(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
(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.
(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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Parkinson Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Daneault, PHd (973-972-8482, jf.daneault@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS-III (Unified Parkinson's Disease Rating Scale) (time frame: Will occur right after the consent received from patients during the first lab visit.). The study lists 6 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 21 Sep 2022.