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Measuring self-reported fatigue in people with ALS and healthy volunteers

Study Purpose:

We are looking for healthy volunteers and individuals with motor neuron disease (ALS, PLS, HSP, SMA) to complete a survey study to help us learn more about fatigue in individuals with motor neuron disease. If you are interested in participating or learning more, please click this link: https://redcap.partners.org/redcap/surveys/?s=94JPCNPJJF

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP), Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

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

Dr. James Berry,  Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital (MGH)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital (MGH)
Zoe Scheier / .(JavaScript must be enabled to view this email address) / 617-643-4803
.(JavaScript must be enabled to view this email address) Boston, Massachusetts 02114 United States

Full Study Summary:

Fatigue is a prevalent, bothersome, and undertreated symptom in patients with amyotrophic lateral sclerosis (ALS) and other motor neuron diseases. There is an urgent need to understand and measure fatigue in people with motor neuron diseases to determine whether therapies are able to treat this symptom and benefit patients. The purpose of this study is to measure patient reported fatigue in people with motor neuron diseases, to compare reported fatigue in people with motor neuron diseases with fatigue in healthy volunteers, and to track changes in fatigue over time. 

Study Sponsor:

Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital (MGH)

Participant Duration:

This study is up to 12 months long. We will ask you to complete a few questionnaires related to your experience of fatigue and related symptoms, at five time points (baseline, 4 weeks, 3 months, 6 months and 12 months).  It will likely take you 30-45 minutes to complete the questionnaires at each time point.

Estimated Enrollment:

1500

Estimated Study Start Date:

12/14/2020

Estimated Study Completion Date:

08/31/2023

Posting Last Modified Date:

12/15/2020

Date Study Added to alsconsortium.org:

12/14/2020
  • More Information

    Why is this important?

    There is a need for more informative, more quantitative measures of fatigue in MND to allow us to track efficacy of treatments aimed at management of fatigue.

    What happens if I sign up?

    • This is a questionnaire only study
    • All visits will be conducted remotely. There will not be any in-person or telephone visits
    • There will be 5 visits over 12 months (baseline, at 4 weeks, 3 months, 6 months and 12 months)
    • For each visit, you will be provided with a link to access a series of questionnaires aimed at helping us better understand fatigue. It will take you approximately 30-45minutes to complete all questionnaires

    Compensation

    There will be no compensation for this study. However, your participation will help develop and implement future studies to quantify the measurement of fatigue, and develop treatments for fatigue in people with motor neuron disease.

    If you are interested in participating or learning more, please click this link: https://redcap.partners.org/redcap/surveys/?s=94JPCNPJJF

  • 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


    We are looking for People with MND and Healthy Participants who are at least 18 years of age and able to complete a series of questionnaires online.

  • Site Contact Information

    Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital (MGH)
    Zoe Scheier / .(JavaScript must be enabled to view this email address) / 617-643-4803
    Boston, Massachusetts 02114
    United States