A Smartphone Application for Neurology and Telemedicine

NCT06245174 | Unknown

• 1 other identifier: R43NS125709
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease(PD)

Keywords

Movement Disorders; Parkinson's Disease; 3D Camera; Smartphone; Motor Assessment; Telehealth

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Parkinson's disease (PD)

Individuals with mild to severe movement disorder symptoms of Parkinson's disease

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or Female;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Altec Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Altec Inc.

Natick, Massachusetts, 01760, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Bhawna Shiwani, MS

  Senior Research Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhawna Shiwani, MS

CONTACT

(508)545-8217; bshiwani@altecresearch.com

Serge Roy, ScD, PT

CONTACT

(508)545-8235; sroy@delsys.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 7, 2024
• Study Start: May 11, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)