ALS Testing through Home-Based Outcome Measures (ALS AT HOME)

Study Purpose:

The purpose of this study is two-fold: to assess the abililty of ALS patients to take their own meaningful outcome measures at home, and to determine whether frequent sampling can increase the reliability of the outcome measures tests.

Disease:

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

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Not Applicable

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

Dr. Jeremy Shefner, MD, PhD, Barrow Neurological Institute

Clinicaltrials.gov ID (11 digit #):

NCT03016897

Neals Affiliated?

Yes

Coordinating Center Contact Information

Barrow Neurological Institute
Kerisa Shelton, PhD / .(JavaScript must be enabled to view this email address) / 602-406-6598
.(JavaScript must be enabled to view this email address) 240 W. Thomas Rd.
Suite 400
Phoenix, Arizona 85013 United States

Full Study Summary:

Barrow Neurological Institute is seeking individuals to participate in a remote research study called ALS AT HOME, enrolling under the direction of Dr. Jeremy Shefner.

In the ALS AT HOME study we hope to show: 1) that ALS patients can evaluate their own function at home, and 2) that taking frequent measures of function will improve the consistency of the tests we use.  If we can demonstrate these things, future research studies may become faster and easier to complete.

This study will involve up to 250 participants; 220 of the participants will be ALS patients, and 30 participants will be healthy individuals. To be eligible for participation, you must be between the ages of 18 and 85, have a Smart Device with Bluetooth capabilities, and have continuous internet access at home.

All of the activities for this study will take place at your home. If you are found to be eligible and are selected for the study, we will ship you the supplies you will need to take your own measurements at home. You will be trained in using the equipment via an online webinar, and you will be instructed to enter data into the study website. Total participation time for this study is nine months. For the first three months you will be asked to enter data daily (this will take approximately 45 minutes per day), and for the last six months you will enter data twice a week. After the study is over, the equipment you were given for the study will be yours to keep.

Study Sponsor:

Barrow Neurological Institute

Participant Duration:

9 Months

Estimated Enrollment:

250

Estimated Study Start Date:

01/01/2017

Estimated Study Completion Date:

12/31/2018

Posting Last Modified Date:

08/02/2017

Date Study Added to alsconsortium.org:

02/27/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    85

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    >36 months

    Can participants use Riluzole?

    Yes


    Own a smartphone with Bluetooth capabilities, continuous internet access at home, willingness to comply with study protocol

  • Site Contact Information

    Barrow Neurological Institute
    Kerisa Shelton, PhD / .(JavaScript must be enabled to view this email address) / 602-406-6598
    Phoenix, Arizona 85013
    United States