Clinical trial NCT02447952: Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis
Official title: An Exploratory Study to Investigate the Use of Biotelemetry to Identify Markers of Disease Progression in Subjects With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Biotelemetry
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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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Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Day Time Wear Time of the Device
timeFrame: Up to Week 48
Secondary outcomes:
Other outcomes:
measure: Duration of Night Time Wear Time of the Device
timeFrame: Up to Week 48
measure: Average Time Spent Active
timeFrame: Up to Week 48
measure: Average Time Spent 'Sedentary Not Lying'
timeFrame: Up to Week 48
measure: Average Time Spent Lying
timeFrame: Up to Week 48
measure: Average Time Spent Sedentary.
timeFrame: Up to Week 48
measure: Time Spent With Sensor Off
timeFrame: Up to Week 48
measure: Total Activity Count
timeFrame: Up to Week 48
measure: Maximum Activity Count in a 24 Hour Period
timeFrame: Up to Week 48
measure: Mean Maximum Activity Count in a 24 Hour Period
timeFrame: Up to Week 48
measure: Number of Continuous Active Periods
timeFrame: Up to Week 48
measure: Percent of Time Lying Down at Night
timeFrame: Up to Week 48
measure: Number of Night Time Movement Episodes Per Hour
timeFrame: Up to Week 48
measure: Percent Time Night-time Rest Efficiency
timeFrame: Up to Week 48
measure: Rest Fragmentation Index
timeFrame: Up to Week 48
measure: Average Duration of Night Time Movement Episodes
timeFrame: Up to Week 48
measure: Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R
timeFrame: Up to Week 48
measure: Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R
timeFrame: Up to Week 48
measure: Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R
timeFrame: Up to Week 48
measure: Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R
timeFrame: Up to Week 48
measure: Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])
timeFrame: Up to Week 48
measure: Variance of HRV While Lying (LF/HF)
timeFrame: Up to Week 48
measure: Mean HRV While Sedentary Not Lying (LF/HF)
timeFrame: Up to Week 48
measure: Variance of HRV While Sedentary Not Lying (LF/HF)
timeFrame: Up to Week 48
measure: Mean HRV While Active (LF/HF)
timeFrame: Up to Week 48
measure: Variance of HRV While Active (LF/HF)
timeFrame: Up to Week 48
measure: Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)
timeFrame: Up to Week 48
measure: Effect of Being Upright on HRV Variance (LF/HF Analysis)
timeFrame: Up to Week 48
measure: Effect of Activity on Mean HRV (LF/HF)
timeFrame: Up to Week 48
measure: Effect of Activity on HRV Variance (LF/HF Analysis)
timeFrame: Up to Week 48
measure: Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)
timeFrame: Up to Week 48
measure: HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis
timeFrame: Up to Week 48
measure: Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R
timeFrame: Up to Week 48
measure: Measurement of Speech Quality
timeFrame: Up to Week 48
measure: Duration of Maximum Gap Between Words
timeFrame: Up to Week 48
measure: Speaking Rate
timeFrame: Up to Week 48
measure: Average Phoneme Rate
timeFrame: Up to Week 48
measure: Maximum Phonation Time
timeFrame: Seconds
measure: Percentage Pause Time
timeFrame: Up to Week 48
measure: Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R
timeFrame: Up to Week 48
measure: Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC
timeFrame: Up to Week 48
measure: Number of Participants Reporting Sensor Comfort
timeFrame: Up to Week 48
measure: Number of Participants Reporting Impact on Sleep
timeFrame: Up to Week 48
measure: Number of Participants With Ease of Setting up and Attaching the Sensor
timeFrame: Up to Week 48
measure: Number of Participants With Corresponding Activity Level Required to Complete Their Job
timeFrame: Up to Week 48
measure: Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor
timeFrame: Up to Week 48
measure: Number of Participants Whose Sensor Fell Off
timeFrame: Up to Week 48
measure: Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures
timeFrame: Up to Week 48
measure: Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures
timeFrame: Up to Week 48
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: