Clinical Trial: Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Exploratory Study to Investigate the Use of Biotelemetry to Identify Markers of Disease Progression in Subjects With Amyotrophic Lateral Sclerosis

Brief Summary:

Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period.

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Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Change over time in measurements of movement/physical activity by accelerometer [ Time Frame: Up to approximately Week 48 ]
  • Relationship between the ALS Functional Rating Scale-Revised (ALSFRS-R) and accelerometer measures of movement/activity. [ Time Frame: Up to approximately week 48 ]
  • Movement/physical activity algorithms validation against in-clinic reference task of movement. [ Time Frame: Up to approximately week 56 ]
  • Change over time in Heart Rate Variability (HRV) [ Time Frame: Up to approximately week 48 ]
  • Relationship between the ALSFRS and biotelemetry measures of HRV. [ Time Frame: Up to approximatelyweek 48 ]
  • Change over time in digital speech measures of vowel, running speech and word measurement. [ Time Frame: Up to approximately Week 48 ]
  • Relationship between the ALSFRS and digital measures of speech [ Time Frame: Up to approximately week 48 ]
  • Relationship between Forced Vital Capacity (FVC) and digital measures of speech [ Time Frame: Up to approximately Week 48 ]
  • Subject/caregiver feedback on ease of device handling. [ Time Frame: Up to approximately week 56 ]
  • Successful biotelemetry data transmission from telecommunications hub to the central secure server at McLaren Applied Technologies (MAT). [ Time Frame: Up to approximately week 56 ]
  • Type of adverse events (AEs) secondary to the devices used in this study or to study procedures. [ Time&

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: GlaxoSmithKline

    Dates:
    Date Received: May 11, 2015
    Date Started: June 30, 2015
    Date Completion: June 1, 2017
    Last Updated: May 15, 2017
    Last Verified: May 2017