Feasibility and Sensitivity of a Symptom Monitoring Application in Real Time (SMART) for ALS

Study Purpose:

The purpose of the research study is to determine how helpful a smartphone application would be in collecting research data and to learn more about disease progression. This is a pilot study in which a smartphone application was designed and customized for use in ALS clinical trials.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

James Berry, MD, MPH, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

Not Applicable

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital
Harli Weber / .(JavaScript must be enabled to view this email address) / 617-643-5376
.(JavaScript must be enabled to view this email address) 55 Fruit Street
Boston, Massachusetts 02114 United States

Full Study Summary:

Massachusetts General Hospital is seeking individuals to participate in a research study enrolling under the direction of James Berry, MD, MPH. The study is funded by Philanthropy, a NIH Grant, and the Neurological Clinical Research Institute. This study is recruiting adults with Amyotrophic Lateral Sclerosis (ALS) who are smartphone users and are able to download and use a smartphone application.

The study asks each participant to use the smartphone application for a few minutes every day by answering a questionnaire/survey, recording your voice and/or performing an on-screen exercise. The purpose of the research study is to determine how helpful a smartphone application would be in collecting research data and to learn more about disease progression. This is a pilot study in which a smartphone application was designed and customized for use in ALS clinical trials.

Individuals with ALS will be in the study for about 3 months and will have the option to extend their participation by another 3 months.

The study is currently recruiting participants who meet the following guideline:

1) Adults with Amyotrophic Lateral Sclerosis (ALS) to download and use the smartphone application using their smartphone device running Android 4.1 or higher

Participants must be at least 18 years of age. Participants should know that these visits can coincide with their routine clinic visits.

Study Sponsor:

Philanthropy, NIH Grant, and the Neurological Clinical Research Institute

Participant Duration:

3 months

Estimated Enrollment:

Estimated Study Start Date:

07/20/2016

Estimated Study Completion Date:

05/22/2017

Posting Last Modified Date:

04/04/2018

Date Study Added to alsconsortium.org:

12/08/2016
  • More Information

    For more information, visit https://clinicaltrials.partners.org/study/9989

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


  • Site Contact Information

    Massachusetts General Hospital
    Harli Weber / .(JavaScript must be enabled to view this email address) / 617-643-5376
    55 Fruit Street
    Boston, Massachusetts 02114
    United States