Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

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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Intervention name(s): Faros Sensor (FS) and LifeInsight Hub; Fast Fix electrode patch; Quantitative Measure of Speech (Core Phase Only)
Intervention type(s): Device; Device; Procedure
Intervention description(s): Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study.; The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch.; Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Amyotrophic Lateral Sclerosis; Biotelemetry