Study to Investigate the Use of Biotelemetry in Subjects with ALS
Research type
Research Study
Full title
An Exploratory Study to Investigate the Use of Biotelemetry to Identify Markers of Disease Progression in Subjects with Amyotrophic Lateral Sclerosis
IRAS ID
167054
Contact name
Kevin Talbot
Contact email
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study is looking at the use of a device to measure movement, activity and heart rate over 48 weeks and how they relate to Amyotrophic Lateral Sclerosis (ALS). It will also measure aspects of speech, using a microphone connected to a laptop computer, and how they relate to ALS. No treatment is provided.
This study is being conducted only in the UK and will include a maximum of 25 participants. It is sponsored by GlaxoSmithKline R&D Limited in collaboration with McLaren Applied Technologies (MAT).
Eligible participants will be aged 50-75, have been diagnosed with ALS within 12 months of symptom onset and not confined to a wheelchair or require mechanical ventilation.
The sensor (like a pedometer) is worn on the body and collects heart rate and activity data. Data is held on the sensor and transferred by wireless link to a Hub. From the Hub, it is transferred via 3G mobile phone network to a secure data store.
About 5 participants will complete a pilot phase which will involve a clinic visit to have the sensor fitted and activities such as walking, lying down and climbing stairs. They will wear the sensor at home for about 3 days then be asked about their experience.
These participants will transition into the Core Phase and enrolment will continue. During the Core Phase participants will visit the clinic every 12 weeks (Weeks 0, 12, 24, 36, and 48) and wear the sensor at home for approximately 3 days each month (Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48). They will be contacted by study staff after each monitoring period and be asked about their experience and ALS symptoms.
All participants will complete the study after Week 48 and will continue with their usual care.REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0080
Date of REC Opinion
26 Feb 2015
REC opinion
Favourable Opinion