About this trial
This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (age 18 and above) presenting with first suspected seizure(s).
Able to give informed consent.
Patient has received an initial epilepsy diagnosis.
Patient accepts decision to commence ASM.
Disqualifiers
Participants unable to tolerate an EEG test so no EEG data were gathered.
Participants with a known hepatic/renal encephalopathy.
Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
Trial population
Patients presenting to the first seizure clinic, receive a routine EEG, receive a diagnosis of epilepsy and are commenced an ASM.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The relationship between BioEP and seizure frequency.
Identify a ratio of change of BioEP result from baseline (prior to ASMs commencing) to maximal effects of the ASM intervention and seizure control.
Secondary outcomes
Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change
The investigators will examine the association between the 12-month change from baseline in BioEP score and reporting at least 'a little improved' on the 7-point patient global impression of change scale. Minimum value 1 = very much improved, maximum value 7 = very much worse A higher score means a worse outcome.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Neuronostics Ltd
Lead sponsor
Cornwall Partnership NHS Foundation Trust
Collaborator
This trial is not recruiting at the moment. You can still explore other options: