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

    deb.pal@kcl.ac.uk

  • 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