A Smartphone Application for Neurology and Telemedicine

Parkinson Disease(PD) Clinical Trial

— NeuroVision  

Official title:

NeuroVision™: A Smartphone Application for Neurology and Telemedicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245174
• Other study ID #: R43NS125709
• Secondary ID: R43NS125709
• Status: Recruiting
• Start date: May 11, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: Altec Inc.
• Contact: Bhawna Shiwani, MS
• Phone: (508)545-8217
• Email: bshiwani[@]altecresearch.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease(PD)

Locations

Country	Name	City	State
United States	Altec Inc.	Natick	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Altec Inc.	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Parkinsonian Gait - Step Length	Step length in centimeters obtained using the NeuroVision prototype while the subject is walking.	5 minute
Primary	Parkinsonian Gait - Step Time	Step time in seconds obtained using the NeuroVision prototype while the subject is walking.	5 minute
Primary	Parkinsonian Gait - Step Variability	Step variability in centimeters obtained using the NeuroVision prototype while the subject is walking.	5 minute
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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