ALS Testing Through Home-based Outcome Measures

NCT03016897 | Completed

• 1 other identifier: BNI_ALS_001
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

ALS AT HOME is a single-center study of up to 150 participants being done to determine the extent to which frequent sampling can improve the qualities of outcome measures collected at home by study participants.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; neurodegenerative

Outcome Measures

Primary Outcomes (8)

• Change in Pulmonary Function

  Respirometer

  Daily for the first 3 months; for the subsequent 6 months measures will be obtained twice weekly

• Change in Quantitative Hand Grip

  Digital Handgrip Meter

  Daily for the first 3 months; for the subsequent 6 months measures will be obtained twice weekly

• Change in Electrical Impedance Myography (EIM) Measurements

  Skulpt Chisel

  Daily for the first 3 months; for the subsequent 6 months measures will be obtained twice weekly

• Change in Actigraphy

  Activity Band

  Daily for the first 3 months; for the subsequent 6 months measures will be obtained twice weekly

• ALSFRS-R

  Questionnaire

  Weekly up to 9 months

• Change in Patient-reported Experience measures (PREMs)

  Questionnaire

  At Week 1, and then at 3, 6, and 9 months

• Adverse Events

  Questionnaire

  Monthly up to 9 months

• Change in Voice/Speech Tracking

  Smartphone application

  Daily for the first 3 months; for the subsequent 6 months measures will be obtained twice weekly

Study Arms (3)

Group 1

Participants enrolled solely in ALS AT HOME Outcome measurement devices will be provided. Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Other: Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Group 2

Current participants of the Answer ALS study Outcome measurement devices will be provided. Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Other: Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Group 3

Participants without neurological disease (controls) Outcome measurement devices will be provided. Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Other: Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Interventions

Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter OTHER

Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patient volunteers will be invited to participate in this study as well as healthy subjects for the control group.

You may qualify if:

• male or female, age 18 to 85 years old,
• ownership of a Smart Device (phone, tablet, etc) with Bluetooth capabilities,
• continuous internet access at home,
• willing and able to provide informed consent in compliance with the regulatory requirements through a web based interface,
• definite, Probable, or Possible ALS by modified El Escorial criteria, as documented by medical records, with duration from diagnosis 60 months or less, and
• for the 50 participants in Group 2, participation in the Answer ALS study.

You may not qualify if:

• diagnosed and actively undergoing treatment for cancer, heart failure, end stage renal disease, or another significant medical condition deemed by the PI to likely affect the participant's ability to comply with the protocol,
• unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol,
• any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.
• Healthy volunteers who have family members with ALS

Sponsors & Collaborators

• Jeremy Shefner: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeremy Shefner, MD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Vice President

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 11, 2017
• Study Start: February 22, 2017
• Primary Completion: June 28, 2019
• Study Completion: September 30, 2019
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)