A Smartphone Application for Neurology and Telemedicine

NCT ID: NCT06245174

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Parkinson Disease(PD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson's disease (PD)

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Altec Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhawna Shiwani, MS

Role: PRINCIPAL_INVESTIGATOR

Senior Research Scientist

Locations

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Altec Inc.

Natick, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bhawna Shiwani, MS

Role: CONTACT

(508)545-8217

Serge Roy, ScD, PT

Role: CONTACT

(508)545-8235

Facility Contacts

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Bhawna Shiwani, MS

Role: primary

508-545-8217

Other Identifiers

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R43NS125709

Identifier Type: NIH

Identifier Source: secondary_id

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R43NS125709

Identifier Type: NIH

Identifier Source: org_study_id

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