A Smartphone Application for Neurology and Telemedicine (NeuroVision)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease(PD)

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Bhawna Shiwani, MS; Phone Number: (508)545-8217; Email: bshiwani@altecresearch.com
• Study Contact Backup: Name: Serge Roy, ScD, PT; Phone Number: (508)545-8235; Email: sroy@delsys.com

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Recruiting
      • Altec Inc.
      • Contact: Bhawna Shiwani, MS; Phone Number: 508-545-8217; Email: bshiwani@altecresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Parkinson's disease (PD); Individuals with mild to severe movement disorder symptoms of Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tremor Duration	Duration in seconds of resting tremor in the hands obtained using the NeuroVision prototype while the subject is sitting at rest.	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.	2 minute
Parkinsonian Gait - Step Length	Step length in centimeters obtained using the NeuroVision prototype while the subject is walking.	5 minute
Parkinsonian Gait - Step Time	Step time in seconds obtained using the NeuroVision prototype while the subject is walking.	5 minute
Parkinsonian Gait - Step Variability	Step variability in centimeters obtained using the NeuroVision prototype while the subject is walking.	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.	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.	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.	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.	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.	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.	2 minute

Collaborators and Investigators

• Sponsor: Altec Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Bhawna Shiwani, MS, Senior Research Scientist

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Telehealth; Smartphone; Movement Disorders; 3D Camera; Motor Assessment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: R43NS125709 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No