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Completed

NCT Number: NCT05823168

Seizures and Traumatic Brain Injury Rehabilitation

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antiepileptic Drug

Drug

we osberve the efficacy of antiepileptic drungs on preventing seizures and their impact on rehabilitation outcome

Other names: antiepileptic prophylactic therapy

Primary outcomes

  1. seizure and rehabilitation

    Time frame: 1 years

    The predictive role of post-traumatic seizure on rehabilitation outcome, assessed with the Functional Independence Measure (FIM).

    The FIM is an 18-item measurement tool that explores a person's disability in terms of burden of care. Each of the 18 items is graded on a scale of 1-7 based on level of independence (1 = total assistance required, 7 = complete independence). The possible total score ranges from 18 (lowest) to 126 (highest) level of independence.

Secondary outcomes

  1. antiepileptic drugs and rehabilitation

    Time frame: 1 years

    The predictive role of antiepileptic prophylactic therapy on rehabilitation outcome, assessed with the Functional Independence Measure (FIM).

    The FIM is an 18-item measurement tool that explores a person's disability in terms of burden of care. Each of the 18 items is graded on a scale of 1-7 based on level of independence (1 = total assistance required, 7 = complete independence). The possible total score ranges from 18 (lowest) to 126 (highest) level of independence.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

The Predictive Role of Seizures and Anitiepileptic Therapy on Rehabilitation Course of Traumatic Brain Injury

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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