DIagnostic Subdural EEG electrodes And Subdural hEmatoma (DISEASE): a study protocol for a prospective nonrandomized controlled trial.

BACKGROUND

Epileptic seizures are common clinical features in patients with acute subdural hematoma (aSDH); however, diagnostic feasibility and therapeutic monitoring remain limited. Surface electroencephalography (EEG) is the major diagnostic tool for the detection of seizures but it might be not sensitive enough to detect all subclinical or nonconvulsive seizures or status epilepticus. Therefore, we have planned a clinical trial to evaluate a novel treatment modality by perioperatively implanting subdural EEG electrodes to diagnose seizures; we will then treat the seizures under therapeutic monitoring and analyze the clinical benefit.

METHODS

In a prospective nonrandomized trial, we aim to include 110 patients with aSDH. Only patients undergoing surgical removal of aSDH will be included; one arm will be treated according to the guidelines of the Brain Trauma Foundation, while the other arm will additionally receive a subdural grid electrode. The study's primary outcome is the comparison of incidence of seizures and time-to-seizure between the interventional and control arms. Invasive therapeutic monitoring will guide treatment with antiseizure drugs (ASDs). The secondary outcome will be the functional outcome for both groups as assessed via the Glasgow Outcome Scale and modified Rankin Scale both at discharge and during 6 months of follow-up. The tertiary outcome will be the evaluation of chronic epilepsy within 2-4 years of follow-up.

DISCUSSION

The implantation of a subdural EEG grid electrode in patients with aSDH is expected to be effective in diagnosing seizures in a timely manner, facilitating treatment with ASDs and monitoring of treatment success. Moreover, the occurrence of epileptiform discharges prior to the manifestation of seizure patterns could be evaluated in order to identify high-risk patients who might benefit from prophylactic treatment with ASDs.

TRIAL REGISTRATION

ClinicalTrials.gov identifier no. NCT04211233.

Informations de copyright

© The Author(s) 2020.

Déclaration de conflit d'intérêts

Competing interestsS.W. declares no competing interest. T.F. declares no competing interest. P.R. declares no competing interest. D.D. declares no competing interest. E.K. declares no competing interests. E.H. declares no competing interests. V.S. declares no competing interest. F.R. reports personal fees and travel support from UCB, EISAI, Bayer-Vital, Shire, cerbomed, Sandoz, Desitin Arzneimittel, Sage Therapeutics, Novartis Oncology, GW Pharma LMU Munich, Schönkliniken, vfa, research support from the European Union, the Detlev-Wrobel-Fonds for Epilepsy Research the DFG, outside the submitted work. A.S. reports personal fees and grants from Desitin Arzneimittel, Eisai, LivaNova, Sage. Therapeutics, UCB Pharma, and Zogenix, outside the submitted work. J.K. declares no competing interest.