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Completed

NCT Number: NCT02447952

Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

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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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 80 years of age, inclusive, at the time of signing the informed consent.
  • Diagnosed with ALS by a neurologist with expertise in ALS. For subjects with bulbar onset there must be objective limb involvement of at least one limb.
  • Diagnosed with ALS within 18 months of symptom onset.
  • Subjects must be ambulatory (i.e., must not be confined to a wheelchair).
  • Male and female subjects.
  • Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in protocol.
  • Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).

Exclusion criteria

  • Neurological (other than the subject's ALS) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.
  • Clinically significant cognitive impairment in the opinion of the investigator.
  • Regionally restricted forms of ALS, or other atypical variants: Isolated corticobulbar pattern of ALS with normal ambulation; Flail arm syndrome; Primary lateral sclerosis; Signs of chronic partial denervation restricted to a single limb; ALS parkinsonism dementia complex
  • Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).
  • Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
  • Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
  • History of skin hypersensitivity to adhesives.
  • Current participation in a clinical trial which in the opinion of the investigator and GSK medical monitor might impact the objectives of this study.

Treatment and study plan

Faros Sensor (FS) and LifeInsight Hub

Device

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.

Fast Fix electrode patch

Device

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.

Quantitative Measure of Speech (Core Phase Only)

Procedure

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.

Primary outcomes

  1. Duration of Day Time Wear Time of the Device

    Time frame: Up to Week 48

    Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent [Active + lying + sedentary not lying] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was <=1.

Other outcomes

  1. Duration of Night Time Wear Time of the Device

    Time frame: Up to Week 48

    Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent [Active + day time lying + day time "sedentary not lying"] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.

  2. Average Time Spent Active

    Time frame: Up to Week 48

    Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

  3. Average Time Spent 'Sedentary Not Lying'

    Time frame: Up to Week 48

    Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  4. Average Time Spent Lying

    Time frame: Up to Week 48

    Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  5. Average Time Spent Sedentary.

    Time frame: Up to Week 48

    Number of minutes spent sedentary [time spent lying + time spent sedentary not lying] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  6. Time Spent With Sensor Off

    Time frame: Up to Week 48

    Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.

  7. Total Activity Count

    Time frame: Up to Week 48

    Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  8. Maximum Activity Count in a 24 Hour Period

    Time frame: Up to Week 48

    Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

  9. Mean Maximum Activity Count in a 24 Hour Period

    Time frame: Up to Week 48

    Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

  10. Number of Continuous Active Periods

    Time frame: Up to Week 48

    Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of 'active periods were calculated as 1minute<x<2minutes + 'number of active periods 2minutes<x<5minutes + 'number of active periods 5minutes<x<15minutes + 'number of active periods 15minutes<x<30minutes + 'number of active periods >30minutes.

  11. Percent of Time Lying Down at Night

    Time frame: Up to Week 48

    Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint

  12. Number of Night Time Movement Episodes Per Hour

    Time frame: Up to Week 48

    Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  13. Percent Time Night-time Rest Efficiency

    Time frame: Up to Week 48

    Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

  14. Rest Fragmentation Index

    Time frame: Up to Week 48

    Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  15. Average Duration of Night Time Movement Episodes

    Time frame: Up to Week 48

    Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  16. Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R

    Time frame: Up to Week 48

    Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented

  17. Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R

    Time frame: Up to Week 48

    Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented

  18. Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R

    Time frame: Up to Week 48

    Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented

  19. Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R

    Time frame: Up to Week 48

    Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented

  20. Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])

    Time frame: Up to Week 48

    Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  21. Variance of HRV While Lying (LF/HF)

    Time frame: Up to Week 48

    Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  22. Mean HRV While Sedentary Not Lying (LF/HF)

    Time frame: Up to Week 48

    Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  23. Variance of HRV While Sedentary Not Lying (LF/HF)

    Time frame: Up to Week 48

    Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  24. Mean HRV While Active (LF/HF)

    Time frame: Up to Week 48

    Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was <=1

  25. Variance of HRV While Active (LF/HF)

    Time frame: Up to Week 48

    Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1

  26. Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)

    Time frame: Up to Week 48

    The effect of being upright on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  27. Effect of Being Upright on HRV Variance (LF/HF Analysis)

    Time frame: Up to Week 48

    The effect of being upright on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  28. Effect of Activity on Mean HRV (LF/HF)

    Time frame: Up to Week 48

    The effect of activity on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.

  29. Effect of Activity on HRV Variance (LF/HF Analysis)

    Time frame: Up to Week 48

    The effect of activity on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.

  30. Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)

    Time frame: Up to Week 48

    Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  31. HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis

    Time frame: Up to Week 48

    HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  32. Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R

    Time frame: Up to Week 48

    Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient

  33. Measurement of Speech Quality

    Time frame: Up to Week 48

    Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  34. Duration of Maximum Gap Between Words

    Time frame: Up to Week 48

    Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.

  35. Speaking Rate

    Time frame: Up to Week 48

    Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  36. Average Phoneme Rate

    Time frame: Up to Week 48

    Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  37. Maximum Phonation Time

    Time frame: Seconds

    Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  38. Percentage Pause Time

    Time frame: Up to Week 48

    Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  39. Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R

    Time frame: Up to Week 48

    Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below

  40. Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC

    Time frame: Up to Week 48

    Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below

  41. Number of Participants Reporting Sensor Comfort

    Time frame: Up to Week 48

    Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  42. Number of Participants Reporting Impact on Sleep

    Time frame: Up to Week 48

    Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  43. Number of Participants With Ease of Setting up and Attaching the Sensor

    Time frame: Up to Week 48

    The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  44. Number of Participants With Corresponding Activity Level Required to Complete Their Job

    Time frame: Up to Week 48

    The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  45. Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor

    Time frame: Up to Week 48

    Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  46. Number of Participants Whose Sensor Fell Off

    Time frame: Up to Week 48

    The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

  47. Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures

    Time frame: Up to Week 48

    Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.

  48. Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures

    Time frame: Up to Week 48

    Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 19, 2015
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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