Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT04211233
Status:
UNKNOWN
Last Update Posted:
2019-12-26
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D006408', 'term': 'Hematoma, Subdural'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-Seizure', 'timeFrame': 'up to 14 days', 'description': 'The time until seizure occurrence will be compared between both arms.'}, {'measure': 'Incidence of seizure', 'timeFrame': '1-7 days', 'description': 'Incidence of seizures will be compared between both arms.'}], 'secondaryOutcomes': [{'measure': 'Modified rankin scale at discharge and follow-up', 'timeFrame': '3-6 months', 'description': 'Modified Rankin Scale:\n\n0 - No symptoms.\n\n1. \\- No significant disability.\n2. \\- Slight disability.\n3. \\- Moderate disability.\n4. \\- Moderately severe disability.\n5. \\- Severe disability.\n6. \\- Dead.'}, {'measure': 'Glasgow outcome scale at discharge and follow-up', 'timeFrame': '3-6months', 'description': 'Glasgow Outcome scale:\n\n1. Death\n2. Persistent vegetative state\n3. Severe disability\n4. Moderate disability\n5. Low disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive grid electrode', 'functional outcome', 'predictors for seizures'], 'conditions': ['Seizures', 'Subdural Hematoma']}, 'referencesModule': {'references': [{'pmid': '33344885', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDespite 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.\n\nDue 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (aged ≥18 years)\n* Symptomatic aSDH needing operative treatment via craniotomy or craniectomy\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with infaust prognosis\n* Asymptomatic patients with conservative treatment\n* aSDH as a secondary diagnosis\n* Concurrent enrollment in any other trial'}, 'identificationModule': {'nctId': 'NCT04211233', 'briefTitle': 'Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE)', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE): Study Protocol for Prospective Non-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DISEASE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Invasive subdural arm', 'description': 'Implantation of invasive subdural electrode in patients after surgical treatment of acute subdural hematoma', 'interventionNames': ['Device: invasive subdural grid electrode']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard treatment arm', 'description': 'Patients with acute subdural hematoma who underwent surgical Treatment and receive Standard medical treatment', 'interventionNames': ['Other: Control arm']}], 'interventions': [{'name': 'invasive subdural grid electrode', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Invasive subdural arm']}, {'name': 'Control arm', 'type': 'OTHER', 'description': 'Standard Treatment based on Brain Trauma Foundation', 'armGroupLabels': ['Standard treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anne Sicking', 'role': 'CONTACT'}, {'name': 'Juergen Konczalla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Sae-Yeon Won, MD', 'role': 'CONTACT', 'email': 'sae-yeon.won@kgu.de', 'phone': '+496963015295'}, {'name': 'Juergen Konczalla, MD PhD', 'role': 'CONTACT', 'email': 'J.konczalla@med.uni-frankfurt.de', 'phone': '+496963015982'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'email contact.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pincipal Investigator', 'investigatorFullName': 'Juergen Konczalla', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}