SHEENA
Research type
Research Study
Full title
Sleep-related Hypermotor Epilepsy Evaluation of Nicotine Administration (SHEENA) - Observational pilot study
IRAS ID
261655
Contact name
Deb Pal
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Sleep-related hypermotor epilepsy (SHE) is a rare focal epilepsy whose genetic aetiology was first elucidated in 1995 - mutations in nAChR receptor subunits CHRNA4 and CHRNB2 are the major known causes but are present in less than 10% of cases. Only 22% of SHE patients achieve seizure remission and 40% are drug-resistant, mandating the need for new treatments. Transdermal nicotine (TN) has proven effective in case studies and in one of our nAChR mutation-positive patients but has not yet been evaluated in a randomised controlled trial. Prior to a definitive trial, some feasibility and pilot work needs to be completed. In this proposal we, therefore, aim to (i) recruit and (ii) collect detailed clinical data from ≥20 suspected SHE patients; (iii) assess nAChR mutation prevalence in SHE cases and perform pre and post-test genetic counselling; (iv) evaluate the prediction properties of clinical features for nAChR mutations (v) observe the effect of Transdermal Nicotine (TN) on seizure frequency and estimate effect size of TN for future trials. We will test the hypothesis that clinical features are an accurate proxy for nAChR mutation.
REC name
London - Westminster Research Ethics Committee
REC reference
21/PR/0058
Date of REC Opinion
8 Apr 2021
REC opinion
Further Information Favourable Opinion