SeizuresNCT04211233
Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)
A study testing invasive subdural grid electrode in people with Seizures and Subdural Hematoma, run by University Clinic Frankfurt at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, Subdural Hematoma
- What is being tested?
- invasive subdural grid electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 20 Dec 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged ≥18 years)
- Symptomatic aSDH needing operative treatment via craniotomy or craniectomy
- Informed consent
Who cannot join
- Patients with infaust prognosis
- Asymptomatic patients with conservative treatment
- aSDH as a secondary diagnosis
- Concurrent enrollment in any other trial
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Goethe University Hospital
Frankfurt am Main
Anne Sicking
Juergen Konczalla, MD
About this study
Official title: Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE): Study Protocol for Prospective Non-randomized Controlled Trial
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.
Read more
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.
- Conditions
- Seizures, Subdural Hematoma
- Being tested
- invasive subdural grid electrode, Control arm
- Keywords
- invasive grid electrode, functional outcome, predictors for seizures
- Medical subject headings
- Seizures, Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive subdural grid electrodeDevice
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.
Control armOther
Standard Treatment based on Brain Trauma Foundation
| Study group | Role | What they receive |
|---|---|---|
| Invasive subdural arm | Active comparator | Implantation of invasive subdural electrode in patients after surgical treatment of acute subdural hematoma Receives: Device: invasive subdural grid electrode |
| Standard treatment arm | Sham comparator | Patients with acute subdural hematoma who underwent surgical Treatment and receive Standard medical treatment Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Seizure
The time until seizure occurrence will be compared between both arms.
Measured: up to 14 days
Incidence of seizure
Incidence of seizures will be compared between both arms.
Measured: 1-7 days
Secondary outcomes (2)
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.
Measured: 3-6 months
Glasgow outcome scale at discharge and follow-up
Glasgow Outcome scale:
- Death
- Persistent vegetative state
- Severe disability
- Moderate disability
- Low disability
Measured: 3-6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start20 Dec 2019 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Konczalla, University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211233
- Sponsor's protocol ID
- DISEASE
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: email contact.
Publications
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.
PubMed 33344885
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE): Study Protocol for Prospective Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04211233
- Acronym / sponsor ID
- DISEASE
- Conditions
- Seizures, Subdural Hematoma
- Keywords
- invasive grid electrode, functional outcome, predictors for seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- 20 Dec 2019 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive subdural arm | Active comparator | Device: invasive subdural grid electrodeImplantation of invasive subdural electrode in patients after surgical treatment of acute subdural hematoma |
| Standard treatment arm | Sham comparator | Other: Control armPatients with acute subdural hematoma who underwent surgical Treatment and receive Standard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged ≥18 years)
- Symptomatic aSDH needing operative treatment via craniotomy or craniectomy
- Informed consent
Key exclusion criteria (4 listed)
- Patients with infaust prognosis
- Asymptomatic patients with conservative treatment
- aSDH as a secondary diagnosis
- Concurrent enrollment in any other trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| invasive subdural grid electrodeA 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. | Device | Invasive subdural arm |
| Control armStandard Treatment based on Brain Trauma Foundation | Other | Standard treatment arm |
Primary outcome
Time-to-Seizure
Time frame: up to 14 days
The time until seizure occurrence will be compared between both arms.
Incidence of seizure
Time frame: 1-7 days
Incidence of seizures will be compared between both arms.
2 secondary outcomes
Modified rankin scale at discharge and follow-up
Time frame: 3-6 months
Glasgow outcome scale at discharge and follow-up
Time frame: 3-6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 33344885Won 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.
- Individual participant dataSharing planned: Undecided. email contact.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing invasive subdural grid electrode in people with Seizures and Subdural Hematoma, run by University Clinic Frankfurt at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sae-Yeon Won, MD (+496963015295, sae-yeon.won@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Seizure (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.