Seizures and Traumatic Brain Injury Rehabilitation

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Seizures; Traumatic Brain Injury
• Intervention / Treatment: Drug: Antiepileptic Drug

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • ICS Maugeriu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with seizures; patients with traumatic brain injury	Drug: Antiepileptic Drug; we osberve the efficacy of antiepileptic drungs on preventing seizures and their impact on rehabilitation outcome; Other Names: antiepileptic prophylactic therapy
patients without seizures; patients with traumatic brain injury	Drug: Antiepileptic Drug; we osberve the efficacy of antiepileptic drungs on preventing seizures and their impact on rehabilitation outcome; Other Names: antiepileptic prophylactic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seizure and rehabilitation	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.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antiepileptic drugs and rehabilitation	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.	1 years

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; outcome; prophylaptic therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Seizures; Anticonvulsants
• Other Study ID Numbers: 2503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No