Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

NCT ID: NCT02447952

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-06-01

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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Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Biotelemetry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pilot and Core Study Phase

During Pilot phase,subjects will attend clinic at least once 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 (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and 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 visits (home monitoring). In between clinic visits, 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

Group Type: EXPERIMENTAL

Faros Sensor (FS) and LifeInsight Hub

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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.

Interventions

Faros Sensor (FS) and LifeInsight Hub

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.

Intervention Type: DEVICE

Fast Fix electrode patch

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.

Intervention Type: DEVICE

Quantitative Measure of Speech (Core Phase Only)

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 Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

201283

Identifier Type: -

Identifier Source: org_study_id