Clinical trial NCT06245174: A Smartphone Application for Neurology and Telemedicine
Official title: NeuroVision™: A Smartphone Application for Neurology and Telemedicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease(PD)
Keywords: Movement Disorders
Parkinson's Disease
3D Camera
Smartphone
Motor Assessment
Telehealth
Lead sponsor: Altec Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* Inability to understand spoken English or follow simple instructions;
* Inability to provide written informed consent.

Primary outcomes:
measure: Tremor Duration
timeFrame: 2 minute
measure: Tremor Amplitude
timeFrame: 2 minute
measure: Parkinsonian Gait - Step Length
timeFrame: 5 minute
measure: Parkinsonian Gait - Step Time
timeFrame: 5 minute
measure: Parkinsonian Gait - Step Variability
timeFrame: 5 minute
measure: Bradykinesia Finger Tap Duration
timeFrame: 2 minute
measure: Bradykinesia Finger Tap Amplitude
timeFrame: 2 minute
measure: Bradykinesia Foot Tap Duration
timeFrame: 2 minute
measure: Bradykinesia Foot Tap Amplitude
timeFrame: 2 minute
measure: Bradykinesia Foot Stomping Duration
timeFrame: 2 minute
measure: Bradykinesia Foot Stomping Amplitude
timeFrame: 2 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: Altec Inc.
state: Massachusetts
Study officials:
affiliation: Senior Research Scientist
name: Bhawna Shiwani, MS
role: PRINCIPAL_INVESTIGATOR
References: