EDoF-S v1.0
Research type
Research Study
Full title
Early Detection of FTD/MND using digital biomarkers: an observational study of Symptomatic frontotemporal dementia and motor neurone disease (EDoF-S)
IRAS ID
327186
Contact name
Jonathan Rohrer
Contact email
Sponsor organisation
UCL Joint Research Office
Clinicaltrials.gov Identifier
Z6364106/2023/10/33, Data protection number
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
As clinical trials in neurodegenerative diseases such as frontotemporal dementia (FTD) and motor neurone disease (MND) move towards treatment within the pre-symptomatic phase of disease, there is a growing need for accessible and sensitive biomarkers of clinical change. The development of wearable technologies and increasing use of smart devices offers a promising solution.
A ‘digital biomarker’ protocol has been developed, which utilises two wearable devices, two non-invasive tests of muscle activity, and two computerised tests, to capture the motor, behavioural and cognitive aspects of FTD and MND.
This study aims to evaluate the symptomatic phase of FTD and MND. Two other studies will run concurrently, utilising the same protocol within a neurologically normal cohort and a pre-symptomatic genetic FTD/MND cohort drawn from the Genetic FTD Initiative (GENFI). The overarching aim is to develop a suite of digital measures that can be deployed remotely to identify clinical changes in people with pre-symptomatic and symptomatic FTD and MND, who are participating in clinical trials.
Participants will be identified via the cognitive and motor neurone disease clinics at the National Hospital for Neurology and Neurosurgery (NHNN) and approached for participation. If they consent to take part in the study they will attend an in-person visit to the Dementia Research Centre (DRC), UCL. Here they will have two non-invasive and safe tests of muscle activity – a muscle ultrasound (US), and a high-density surface electromyogram (HDSEMG). They will be provided with devices (Fitbit, Axivity AX6 Inertial Measurement Unit (IMU), iPad mini) to take home and use over the following four weeks. A courier will collect their devices on completion of the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0395
Date of REC Opinion
24 Nov 2023
REC opinion
Further Information Favourable Opinion