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

Study Status:

Not recruiting

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

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

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:

Neals Affiliated?

No

Coordinating Center Contact Information

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

Alison Clark / email hidden; JavaScript is required / 617-726-4284

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 / 01 / 2022

Date Study Added to neals.org:

12 / 14 / 2020

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

Minimum Age:

18

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.

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

Alison Clark / 617-726-4284 / email hidden; JavaScript is required

Amrita Iyer / 617-643-9550 / email hidden; JavaScript is required

Boston, Massachusetts 02114
United States