Seizures and Traumatic Brain Injury Rehabilitation

NCT05823168 | Completed

• 1 other identifier: 2503
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Seizures; Traumatic Brain Injury

Keywords

rehabilitation; outcome; prophylaptic therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• antiepileptic drugs and rehabilitation

  1 years

Study Arms (2)

patients with seizures

patients with traumatic brain injury

Drug: Antiepileptic Drug

patients without seizures

patients with traumatic brain injury

Drug: Antiepileptic Drug

Interventions

Antiepileptic Drug DRUG

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

Also known as: antiepileptic prophylactic therapy

patients with seizures; patients without seizures

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

ICS Maugeri

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 38587858 BACKGROUND

MeSH Terms

Conditions

Seizures; Brain Injuries, Traumatic

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 21, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 14, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)