Experience sampling methodology to assess seizure-risk modulators
Research type
Research Study
Full title
Remote assessment of Disease and Relapse in Central Nervous System Disorders (RADAR-CNS) Experience sampling methodology to assess seizure-risk modulators: an observational study
IRAS ID
245902
Contact name
Elisa Bruno
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Epilepsy is one of the most common neurological disorders, affecting about 0.6% of the population worldwide and 750,000 people in the United Kingdom (UK). Although defined as a condition characterized by mostly unprovoked and unpredictable seizures, patients often self-identify and report specific factors affecting seizure control and leading to increased seizure likelihood over a relatively brief time period. A seizure precipitant or trigger can be defined as any endogenous or exogenous factor promoting the occurrence of epileptic seizures. Examples of precipitants include stress, menstrual cycle, sleep and sleep deprivation, mood and anxiety.
Research studies to identify precipitants assess patients with the use of cross-sectional questionnaires and diaries. These methods are subject to recall bias, as self-reported seizure occurrence is known to be highly unreliable. Also in prospective studies, diaries may be completed retrospectively and a time stamp is not available. Another factor to take into account is that, besides the interactions among well-known precipitants, less known and more difficult to measure variables, namely environmental variables could modulate seizure precipitation. Thus, a full assessment of seizure precipitants, their interactions and their role in seizure occurrence cannot omit the domestic/environment effect and may only be clarified by assessing the patient with objective and real-time measurements in a routine (natural) environment.
The use of new ambulatory assessment technologies, allowing a continuous and objective monitoring of a great range of parameters in a daily-life environment (remote monitoring technology-RMT) and an excellent temporal resolution, might represent an ideal tool for precipitants assessment. In particular, experience sampling methodology (ESM, or active RMT), a structured ambulatory, real-life assessment technique, administered via smartphones, provides a context-sensitive fine-grained assessment of behaviour, cognition, stress in the context of daily life.REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1224
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion