Parkinson Disease(PD)NeuroVisionNCT06245174
A Smartphone Application for Neurology and Telemedicine
An observational study of Parkinson Disease(PD), run by Altec Inc. at 1 site in United States.
Trial summary
This observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson Disease(PD)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2023to 30 Sep 2025
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons who have Parkinson's disease under a doctor's care for movement disorder management at a primary-care or specialty (neurology) out-patient clinic.
Who may be able to join
- Male or Female;
- 35 years of age or older;
- Physician-diagnosed Parkinson's disease or other movement disorder such as Essential Tremor or Dystonia;
- One or more mild to moderate motor symptoms of PD (tremor, bradykinesia, akinesia, Parkinsonian gait);
- Hohn and Yahr (Stage I-III);
- Independent ambulator - walker or cane allowed;
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- Referring neurologist indicates that prospective subject is not at high fall risk and can safely participate in the study;
- Have participated in prior telehealth visits using videoconferencing app;
- Have used a smartphone in past to record videos;
- Able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
- American-English speaking; able to follow directions in English;
- Normal hearing.
Who cannot join
- Inability to understand spoken English or follow simple instructions;
- Inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Altec Inc.
Natick, Massachusetts, 01760
Bhawna Shiwani, MS, 508-545-8217, bshiwani@altecresearch.com
About this study
Official title: NeuroVision™: A Smartphone Application for Neurology and Telemedicine
This observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with Parkinson's disease (PD). The goal of this study is to validate the motor outcomes derived from a consumer camera observing a sub-set of standardized assessment tasks with respect to the reference motion capture system.
Read the detailed description
The long-term goal of this project is to develop a new software application (NeuroVision App) for a smartphone or tablet that can be used in the home to measure abnormal body movements associated with Parkinson's disease (PD). The outcomes are intended to enhance PD symptom monitoring in the context of telehealth videoconferences with a clinician. Typical abnormal body movements that can be assessed with the proposed solution include uncontrolled shaking of hands and limbs (tremor) or spastic movements (dyskinesia) while at rest; abnormally slow movements when reaching or walking (bradykinesia); or inability to initiate a movement (akinesia) using 5 standardized motor assessment tasks (sitting at rest, walking, finger tapping, foot tapping, and foot stomping) derived from the Unified Parkinsons Disease Rating Scale (UPDRS). The proposed solution will make it easier for the doctor to periodically assess the motor signs of PD during remote telehealth appointments which may be more convenient and safer for the patient. Current reliance on videoconferencing apps make it difficult to record and measure such symptoms accurately in a telehealth setting.
- Conditions
- Parkinson Disease(PD)
- Keywords
- Movement Disorders, Parkinson's Disease, 3D Camera, Smartphone, Motor Assessment, Telehealth
- Medical subject headings
- Parkinson Disease, 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 |
|---|---|---|
| Parkinson's disease (PD) | Individuals with mild to severe movement disorder symptoms of Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Duration
Duration in seconds of resting tremor in the hands obtained using the NeuroVision prototype while the subject is sitting at rest.
Measured: 2 minute
Tremor Amplitude
Amplitude in centimeters of resting tremor in the hands obtained using the NeuroVision prototype while the subject is sitting at rest.
Measured: 2 minute
Parkinsonian Gait - Step Length
Step length in centimeters obtained using the NeuroVision prototype while the subject is walking.
Measured: 5 minute
Parkinsonian Gait - Step Time
Step time in seconds obtained using the NeuroVision prototype while the subject is walking.
Measured: 5 minute
Parkinsonian Gait - Step Variability
Step variability in centimeters obtained using the NeuroVision prototype while the subject is walking.
Measured: 5 minute
Bradykinesia Finger Tap Duration
Duration in seconds of a finger tapping task obtained using the NeuroVision prototype while the subject opens and closes their hand as rapidly as possible.
Measured: 2 minute
Bradykinesia Finger Tap Amplitude
Amplitude in centimeters of a finger tapping task obtained using the NeuroVision prototype while the subject opens and closes their hand as rapidly as possible.
Measured: 2 minute
Bradykinesia Foot Tap Duration
Duration in seconds of a foot tapping task obtained using the NeuroVision prototype while the subject taps their toes on the floor as rapidly as possible.
Measured: 2 minute
Bradykinesia Foot Tap Amplitude
Amplitude in centimeters of a foot tapping task obtained using the NeuroVision prototype while the subject taps their toes on the floor as rapidly as possible.
Measured: 2 minute
Bradykinesia Foot Stomping Duration
Duration in seconds of a foot stomping task obtained using the NeuroVision prototype while the subject lifts and lowers their foot on the floor as rapidly as possible.
Measured: 2 minute
Bradykinesia Foot Stomping Amplitude
Amplitude in centimeters of a foot stomping task obtained using the NeuroVision prototype while the subject lifts and lowers their foot on the floor as rapidly as possible.
Measured: 2 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start11 May 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhawna Shiwani, MS, Principal investigator, Senior Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245174
- Sponsor's protocol ID
- R43NS125709
- Other IDs
- R43NS125709
- Acronym
- NeuroVision
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroVision™: A Smartphone Application for Neurology and Telemedicine
- ClinicalTrials.gov ID
- NCT06245174
- Acronym / sponsor ID
- NeuroVision / R43NS125709
- Conditions
- Parkinson Disease(PD)
- Keywords
- Movement Disorders, Parkinson's Disease, 3D Camera, Smartphone, Motor Assessment, Telehealth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Altec Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Feb 2024 (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.
This observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with Parkinson's disease (PD). The goal of this study is to validate the motor outcomes derived from a consumer camera observing a sub-set of standardized assessment tasks with respect to the reference motion capture system.
Detailed description
The long-term goal of this project is to develop a new software application (NeuroVision App) for a smartphone or tablet that can be used in the home to measure abnormal body movements associated with Parkinson's disease (PD). The outcomes are intended to enhance PD symptom monitoring in the context of telehealth videoconferences with a clinician. Typical abnormal body movements that can be assessed with the proposed solution include uncontrolled shaking of hands and limbs (tremor) or spastic movements (dyskinesia) while at rest; abnormally slow movements when reaching or walking (bradykinesia); or inability to initiate a movement (akinesia) using 5 standardized motor assessment tasks (sitting at rest, walking, finger tapping, foot tapping, and foot stomping) derived from the Unified Parkinsons Disease Rating Scale (UPDRS). The proposed solution will make it easier for the doctor to periodically assess the motor signs of PD during remote telehealth appointments which may be more convenient and safer for the patient. Current reliance on videoconferencing apps make it difficult to record and measure such symptoms accurately in a telehealth setting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease (PD) | – | –Individuals with mild to severe movement disorder symptoms of Parkinson's disease |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons who have Parkinson's disease under a doctor's care for movement disorder management at a primary-care or specialty (neurology) out-patient clinic.
Key inclusion criteria (12 listed)
- Male or Female;
- 35 years of age or older;
- Physician-diagnosed Parkinson's disease or other movement disorder such as Essential Tremor or Dystonia;
- One or more mild to moderate motor symptoms of PD (tremor, bradykinesia, akinesia, Parkinsonian gait);
- Hohn and Yahr (Stage I-III);
Key exclusion criteria (2 listed)
- Inability to understand spoken English or follow simple instructions;
- Inability to provide written informed consent.
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
Tremor Duration
Time frame: 2 minute
Duration in seconds of resting tremor in the hands obtained using the NeuroVision prototype while the subject is sitting at rest.
Tremor Amplitude
Time frame: 2 minute
Amplitude in centimeters of resting tremor in the hands obtained using the NeuroVision prototype while the subject is sitting at rest.
Parkinsonian Gait - Step Length
Time frame: 5 minute
Step length in centimeters obtained using the NeuroVision prototype while the subject is walking.
Parkinsonian Gait - Step Time
Time frame: 5 minute
Step time in seconds obtained using the NeuroVision prototype while the subject is walking.
Parkinsonian Gait - Step Variability
Time frame: 5 minute
Step variability in centimeters obtained using the NeuroVision prototype while the subject is walking.
Bradykinesia Finger Tap Duration
Time frame: 2 minute
Duration in seconds of a finger tapping task obtained using the NeuroVision prototype while the subject opens and closes their hand as rapidly as possible.
Bradykinesia Finger Tap Amplitude
Time frame: 2 minute
Amplitude in centimeters of a finger tapping task obtained using the NeuroVision prototype while the subject opens and closes their hand as rapidly as possible.
Bradykinesia Foot Tap Duration
Time frame: 2 minute
Duration in seconds of a foot tapping task obtained using the NeuroVision prototype while the subject taps their toes on the floor as rapidly as possible.
Bradykinesia Foot Tap Amplitude
Time frame: 2 minute
Amplitude in centimeters of a foot tapping task obtained using the NeuroVision prototype while the subject taps their toes on the floor as rapidly as possible.
Bradykinesia Foot Stomping Duration
Time frame: 2 minute
Duration in seconds of a foot stomping task obtained using the NeuroVision prototype while the subject lifts and lowers their foot on the floor as rapidly as possible.
Bradykinesia Foot Stomping Amplitude
Time frame: 2 minute
Amplitude in centimeters of a foot stomping task obtained using the NeuroVision prototype while the subject lifts and lowers their foot on the floor as rapidly as possible.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Bhawna Shiwani, MS principal investigator
Senior Research Scientist
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 Parkinson Disease(PD), run by Altec Inc. 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 12 inclusion and 2 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 30 Jul 2024. 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 Bhawna Shiwani, MS ((508)545-8217, bshiwani@altecresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor Duration (time frame: 2 minute). The study lists 11 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 30 Jul 2024.