Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)
Primary Purpose
Seizures, Subdural Hematoma
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
invasive subdural grid electrode
Control arm
Sponsored by
About this trial
This is an interventional diagnostic trial for Seizures focused on measuring invasive grid electrode, functional outcome, predictors for seizures
Eligibility Criteria
Inclusion Criteria:
- Adult patients (aged ≥18 years)
- Symptomatic aSDH needing operative treatment via craniotomy or craniectomy
- Informed consent
Exclusion Criteria:
- Patients with infaust prognosis
- Asymptomatic patients with conservative treatment
- aSDH as a secondary diagnosis
- Concurrent enrollment in any other trial
Sites / Locations
- Goethe University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Invasive subdural arm
Standard treatment arm
Arm Description
Implantation of invasive subdural electrode in patients after surgical treatment of acute subdural hematoma
Patients with acute subdural hematoma who underwent surgical Treatment and receive Standard medical treatment
Outcomes
Primary Outcome Measures
Time-to-Seizure
The time until seizure occurrence will be compared between both arms.
Incidence of seizure
Incidence of seizures will be compared between both arms.
Secondary Outcome Measures
Modified rankin scale at discharge and follow-up
Modified Rankin Scale:
0 - No symptoms.
- No significant disability.
- Slight disability.
- Moderate disability.
- Moderately severe disability.
- Severe disability.
- Dead.
Glasgow outcome scale at discharge and follow-up
Glasgow Outcome scale:
Death
Persistent vegetative state
Severe disability
Moderate disability
Low disability
Full Information
NCT ID
NCT04211233
First Posted
December 18, 2019
Last Updated
December 24, 2019
Sponsor
University Clinic Frankfurt
1. Study Identification
Unique Protocol Identification Number
NCT04211233
Brief Title
Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)
Official Title
Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE): Study Protocol for Prospective Non-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Anticipated)
Primary Completion Date
December 20, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinic Frankfurt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Epileptic seizures are one of the frequent complications in patients with traumatic brain injury; the incidence lies approximately at 20%. Particularly, acute subdural hematoma (aSDH) is one of the most important predictors for epileptic seizures, which is besides other parameters like age, preoperative Glasgow coma scale, cerebral herniation, hematoma volume and time to operation, associated with worse neurological outcome. In a recent systematic review, the mean incidence of epileptic seizures in aSDH was 28%, whereas one retrospective study focusing on EEG-diagnostic reported very high incidence of epileptiform abnormalities on surface EEG in 87% of patients with aSDH, wherefore the question rises, if the incidence of epileptic seizures is underestimated.
Despite successful evacuation of subdural hematoma, approximately one third of patients show no clinical improvement without medical explanation. Routinely, surface spot EEG is performed to detect epileptic seizures; however the sensitivity is limited due to the skin-bone barrier and the short duration of recording. Furthermore, surface EEG is not always available, for example during the night or at weekends, which is an additional limitation for the loss of treatment timing as well. Spot surface EEG will record for only 20 to 30 minutes in contrast to continuous EEG recordings that are performed for hours or days.
Due to the clinical relevance of epileptic seizures, several studies investigated the benefit of prophylactic antiepileptic treatment. To date, there is only one recommendation from the Brain Trauma Foundation at evidence class II to treat patients with severe traumatic brain injury with prophylactic antiepileptic treatment during the first week. Beyond the interval; there was no clinical benefit for patients selected. Still, there are some limitations´wherefore the clinical use of prophylactic antiepileptic treatment varies between clinicians and countries. At that time, the standard medication was phenytoin which has several side effects, but to date, there are several new intravenous antiepileptic drugs with comparable effect but better safety profile. On the other hand, there was no sifferentiation made between high-risked seizure prone patients, like patients with aSDH, and low-risked patients which is one of the limiting factors to support a general recommendation. Therefore the role of prophylactic antiepileptic treatment is still questionable.
In the clinical routine, invasive EEG-electrodes are commonly used to detect epileptic focus. The benefit of those electrodes is the real time analysis in case of seizure occurrence compared to surface EEG. Moreover, therapeutic effect is directly visible through the monitoring. Therefore the idea of this study was to make a real time analysis possible for patient with TBI, particularly aSDH, to have diagnostic and therapeutic real time monitoring detecting subclinical seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Subdural Hematoma
Keywords
invasive grid electrode, functional outcome, predictors for seizures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Invasive subdural arm
Arm Type
Active Comparator
Arm Description
Implantation of invasive subdural electrode in patients after surgical treatment of acute subdural hematoma
Arm Title
Standard treatment arm
Arm Type
Sham Comparator
Arm Description
Patients with acute subdural hematoma who underwent surgical Treatment and receive Standard medical treatment
Intervention Type
Device
Intervention Name(s)
invasive subdural grid electrode
Intervention Description
A subdural EEG-electrode (PLATIN 1x4 or 1x6; Ad-Tech Medical Instrument Corporation, Oak Creek, WI, USA, Figure 1) will be implanted in the subdural space frontotemporal intraoperatively and diverted separately from the wound area. Afterwards, invasive Monitoring will be performed for 7 days and the grid will be removed simply by pulling out.
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
Standard Treatment based on Brain Trauma Foundation
Primary Outcome Measure Information:
Title
Time-to-Seizure
Description
The time until seizure occurrence will be compared between both arms.
Time Frame
up to 14 days
Title
Incidence of seizure
Description
Incidence of seizures will be compared between both arms.
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Modified rankin scale at discharge and follow-up
Description
Modified Rankin Scale:
0 - No symptoms.
- No significant disability.
- Slight disability.
- Moderate disability.
- Moderately severe disability.
- Severe disability.
- Dead.
Time Frame
3-6 months
Title
Glasgow outcome scale at discharge and follow-up
Description
Glasgow Outcome scale:
Death
Persistent vegetative state
Severe disability
Moderate disability
Low disability
Time Frame
3-6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (aged ≥18 years)
Symptomatic aSDH needing operative treatment via craniotomy or craniectomy
Informed consent
Exclusion Criteria:
Patients with infaust prognosis
Asymptomatic patients with conservative treatment
aSDH as a secondary diagnosis
Concurrent enrollment in any other trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sae-Yeon Won, MD
Phone
+496963015295
Email
sae-yeon.won@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Konczalla, MD PhD
Phone
+496963015982
Email
J.konczalla@med.uni-frankfurt.de
Facility Information:
Facility Name
Goethe University Hospital
City
Frankfurt/Main
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Sicking
First Name & Middle Initial & Last Name & Degree
Juergen Konczalla, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
email contact.
Citations:
PubMed Identifier
33344885
Citation
Won SY, Freiman TM, Reif PS, Dubinski D, Hattingen E, Herrmann E, Seifert V, Rosenow F, Strzelczyk A, Konczalla J. DIagnostic Subdural EEG electrodes And Subdural hEmatoma (DISEASE): a study protocol for a prospective nonrandomized controlled trial. Neurol Res Pract. 2020 Dec 15;2:50. doi: 10.1186/s42466-020-00096-8. eCollection 2020.
Results Reference
derived
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Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)
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