Signature 2 (extention study)
Research type
Research Study
Full title
Are sympatho-vagal balance measures derived from heart rate variability during seizures helping in defining the cause of the seizure: a pilot study. Further data acquisition in order to improve quality of data for analysis
IRAS ID
210787
Contact name
Paul N Cooper
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Blackouts, better termed “Transient Loss of Consciousness” can be due to fainting, epilepsy or psychological causes. Most patients with blackouts are unable to describe their blackout, and often no good description is available from a witness.
When a person has continuing blackouts, and there is significant uncertainty about the diagnosis, patients are admitted to a monitoring unit for up to a week, to continuously record their electroencephalogram (EEG) and electrocardiogram (ECG), and observe what happens to them, and to their EEG and ECG, during a blackout.
Cardiac function is under the control of the autonomic nervous system, and using advanced signal analysis techniques it is possible to measure the state of the autonomic nervous system from the ECG trace; our hypothesis is that analysis of the level of autonomic arousal prior to the blackout defines distinct "signatures" which may help define the cause of the collapse.
In the current study we intend to use existing data collected during routine clinical monitoring to see if it possible to extract suitable ECG data from the recordings. The findings from this pilot study will help determine if further studies are warranted to develop this technique for future patient benefit.
In our previous pilot study 146807 we have found that it has proved difficult to obtain a clear ECG signal for data analysis, and we need to alter recording parameters to improve signal quality. This, we believe, supports the use of the previous pilot to establish the quality of the data, we now need to go back and try to improve the quality of the ECG signal.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1388
Date of REC Opinion
1 Aug 2016
REC opinion
Favourable Opinion