Recruiting

Quality of Life

Sponsor:

TidalHealth, Inc.

Code:

NCT07491484

Conditions

Amyotrophic Lateral Sclerosis

Motor Neuron Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Amyotrophic Lateral Sclerosis Assessment Questionnaire-40

Study Details

Brief summary:

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disease in which motor neuron cells of the brain and spinal cord progressively degenerate and die. There is currently a lack of curative treatment for individuals that are diagnosed with ALS. Since treatment options are limited, researchers have placed greater emphasis on evaluating Quality-of-Life (QoL) as it offers perspective into the everyday life of the patient and is sensitive to changes over time.

The goal of this longitudinal observational study is to learn more about what factors negatively impact an individual's QoL after they are diagnosed with ALS. Previous research has shown that an individual's level of physical functioning can negatively impact their quality of life, but this may not be the only factor.

The main objectives this study are:

1. Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).
2. Determine how disease stage (King's Clinical Severity Staging System) affects correlation between functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).

Participants will complete a quality-of-life questionnaire (ALSAQ-40) every other time they present to their standard-of-care clinic visits for a period of two years. In parallel, with the functionality rating (ALSFRS-R) scores captured as standard-of-care at every clinic visit.

Conditions

Amyotrophic Lateral Sclerosis

Motor Neuron Disease

Study ID

NCT07491484

Start date

Jul 3, 2025

Status verified date

Mar, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Over the age of 18
  • Have a diagnosis of Amyotrophic Lateral Sclerosis of Motor Neuron Disease
  • Able to comprehend and willing to sign an informed consent form and comply with study procedures.
  • Receiving care at TidalHealth Peninsula Regional Multidisciplinary ALS Clinic

Exclusion Criteria:

  • Unable to read and understand English
  • Unwilling or unable to comply with the study procedure, including the presence of any condition that is likely to affect the participant's ability to comply with study procedures.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Patient-Reported Functionality Assessment

Amyotrophic Lateral Sclerosis Assessment Questionnaire-40

Patient-Reported Quality-of-Life Assessment

Primary outcome measure

  • Results of the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) [ Time Frame: Assessment will start at the initial visit, then every other standard-of-care clinic visit, through study completion (assessed up to 2 years). ]
  • Results of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years). ]

Central Contacts and Locations

Central contacts

Allison D Elerding, MS

410-912-6122Allison.Elerding@tidalhealth.org

Locations

TidalHealth Peninsula Regional, Inc.

Recruiting

Salisbury, Maryland, United States, 21801

Contacts

Allison D Elerding, MS

410-912-6122Allison.Elerding@tidalhealth.org

More Information

Sponsor

TidalHealth, Inc.

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • Quality of Life
  • ALSAQ-40
  • ALSFRS-R
  • Physical Functioning
  • Patient Reported Outcomes
  • PRO
  • King's Clinical Severity Staging System
  • QoL
  • Amyotrophic Lateral Sclerosis
  • ALS
  • Motor Neuron Disease
  • MND

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TidalHealth, Inc. on 2026-03-24.