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

Abstract

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.

The Long-Term Use of Diagnostic Subdural Electroencephalogram Electrodes and Subdural Hematoma: A Prospective Cohort Study*

“…This single-center, prospective, cohort trial recruited patients between September 2016 and December 2019, as outlined in the study protocol (ClinicalTrials.gov Identifier No. NCT04211233) (9). Patients 18 years old or older who were admitted for the treatment of traumatic aSDH were screened for eligibility; all patients who were treated surgically via craniotomy or craniectomy were included in this study.…”

“…gov Identifier No. NCT04211233) (9). Patients 18 years old or older who were admitted for the treatment of traumatic aSDH were screened for eligibility; all patients who were treated surgically via craniotomy or craniectomy were included in this study.…”

Seizures After Acute Subdural Hemorrhage: Call for More Monitoring*

“…It is in this context that we consider the recent article by Won et al (7) in this issue of Critical Care Medicine . The study by Won et al (7) performed a systematic study of combined surface and intracranial EEG (iEEG) using a brain surface strip electrode near the region of SDH evacuation.…”

“…Given the high incidence of seizures, it would be prudent for patients with recent TBI and recent SDH evacuation to be monitored for seizures using EEG. One would also consider providing anti-seizure medication to this specific group of TBI patients.There are some concerns with the report by Won et al (7). The first concern is that the patients were not provided prophylactic anti-seizure medications perioperatively.…”

“…There are some concerns with the report by Won et al (7). The first concern is that the patients were not provided prophylactic anti-seizure medications perioperatively.…”