Clinical trial NCT05823168: Seizures and Traumatic Brain Injury Rehabilitation
Official title: The Predictive Role of Seizures and Anitiepileptic Therapy on Rehabilitation Course of Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Traumatic Brain Injury
Keywords: rehabilitation
outcome
prophylaptic therapy
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this multicentric italian prospective study were enrolled adult patients admitted to intesive inpatients rehabilitation programme afther traumatic brain injury.

The following data were collected: age at the time of the brain injury, sex, presence of subarachnoid hemorrhage, associated neurosurgical procedures, neurological and functional assessments, occurrence of seizures in either the intensive care or rehabilitation units, use and type of AEDs, death during hospitalization.

Brief summary: post-traumatic seizures (PTS) are a common and debilitating complication of traumatic brain injury (TBI) and could have harmful impact on patient disabilty and rehabilitation outcome.

In this multicentric prospective observational study we aimed to evaluate the role on functional outcome of patients admitted to neurorehabilitation unit afther traumatic brain injury of:

* newly occurring seizures
* prescription of antiepileptic prophylactic therapy

The inclusion criteria were the following: 1) age ≥ 18; 2) diagnosis of TBI on presentation; 3) admission to a hospital emergency department within 24 h of injury; 4) admission within one month from the injury to the rehabilitation unit to continue clinical care and rehabilitation program; 5) up to 6 months of observation in rehabilitation setting.

Were collected the following variables: gender, medical history, age at occurrence of injury, injury characteristics, fracture site, presence of penetrating TBI, presence of subarachnoid haemorrhage, associated neurosurgical procedures (craniotomy, cranioplasty), neurologic and functional assessments, brain imaging, occurrence of seizure, presence and type of anticonvulsant therapy, death during hospitalization.

The investigator analysed through logistic regression variables predictors of risk occurrence of seizure, and neurological and functional outcome, respectively assessed with the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM).

Detailed description: Seizures represent a well-known complication of acute brain injury (ABI). They can occur from the first days up to several years after ABI, with different pathophysiological mechanisms mainly depending on when they occur. In particular, acute symptomatic seizures , which occur within seven days from ABI, are thought to be directly related to acute and possibly reversible neuronal dysfunction, whereas unprovoked seizures (US), which occur after more than seven days, might follow structural changes in neuronal networks. US are associated with a persistent predisposition to generate seizures, being therefore part of an epilepsy condition. Treatment of US with antiepileptic drugs (AEDs) soon after their first appearance represents the standard care after ABI, regardless of their etiology. Beyond this practice, the post-ABI indiscriminate prescription of AEDs as preventive therapy for seizures remains controversial, even though they can potentially affect neurological outcomes in many conditions, such as TBI, ischemic and hemorrhagic stroke, and in ABI patients undergoing craniectomy or craniotomy. As a major concern, the use of AEDs for seizure prophylaxis seems to be irrelevant for the neurological outcome and mortality, and to increase the frequency of side effects, such as cognitive and behavioral complications. In this multicentric italian study, we conducted a prospective analysis on the occurrence of seizures and use of AEDs in a large cohort of patients with ABI admitted to rehabilitation, evaluating data available from admission to up to 6 months after TBI. The aim was to evaluate the effects of newly occurring seizures and of AED therapy on functional outcome, and the efficacy of AEDs as preventive treatment for seizures.

The inclusion criteria were the following: 1) age ≥ 18; 2) diagnosis of TBI on presentation; 3) admission to a hospital emergency department within 24 h of injury; 4) admission within one month from the injury to the rehabilitation unit to continue clinical care and rehabilitation program; 5) up to 6 months of observation in rehabilitation setting.

Were collected the following variables: gender, medical history, age at occurrence of injury, injury characteristics, fracture site, presence of penetrating TBI, presence of subarachnoid haemorrhage, associated neurosurgical procedures (craniotomy, cranioplasty), neurologic and functional assessments, brain imaging, occurrence of seizure, presence and type of anticonvulsant therapy, death during hospitalization. Furthermore, were specifically recorded the occurrence of seizures during both acute and rehabilitation hospitalizations. Finally, were collected data from the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM), respectively to evaluate the neurological and functional outcome. GCS is used not only to classify severity of TBI and trend its course, but also as a validated predictor of clinical outcome after TBI.

The investigator analysed through logistic regression variables predictors of risk occurrence of seizure, and neurological and functional outcome, respectively assessed with the GCS and the FIM.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* diagnosis of Traumatic Brain injury;
* admission to our rehabilitation unit within one month from the brain injury to continue clinical care and rehabilitation programs started in the intensive care unit (ICU);
* at least 6 months of observation before the discharge.

Exclusion Criteria:

* previous brain injury, or any other neurological disease;
* history of epilepsy and/or concurrent use of AEDs;
* AED prescription for psychiatric disorders;
* lack of detailed clinical data about the care during the acute phase.

Primary outcomes:
measure: seizure and rehabilitation
timeFrame: 1 years
Secondary outcomes:
measure: antiepileptic drugs and rehabilitation
timeFrame: 1 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: ICS Maugeri
Study officials:
References:
citation: Pease M, Mittal A, Merkaj S, Okonkwo DO, Gonzalez-Martinez JA, Elmer J, Liou WS, Pingue V, Hammond FM, Abramovici S, Castellano J, Barot N. Early Seizure Prophylaxis in Mild and Moderate Traumatic Brain Injury: A Systematic Review and Meta-Analysis. JAMA Neurol. 2024 May 1;81(5):507-514. doi: 10.1001/jamaneurol.2024.0689.