SeizuresNCT05823168
Seizures and Traumatic Brain Injury Rehabilitation
An observational study of Seizures and Traumatic Brain Injury, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Seizures, Traumatic Brain Injury
- What is being tested?
- Antiepileptic Drug
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 14 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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).
Read the 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.
- Conditions
- Seizures, Traumatic Brain Injury
- Being tested
- Antiepileptic Drug
- Keywords
- rehabilitation, outcome, prophylaptic therapy
- Medical subject headings
- Seizures, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiepileptic DrugDrug
Also called antiepileptic prophylactic therapy
we osberve the efficacy of antiepileptic drungs on preventing seizures and their impact on rehabilitation outcome
| Study group | Role | What they receive |
|---|---|---|
| patients with seizures | patients with traumatic brain injury Receives: Drug: Antiepileptic Drug | |
| patients without seizures | patients with traumatic brain injury Receives: Drug: Antiepileptic Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (1)
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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823168
- Sponsor's protocol ID
- 2503
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38587858
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of Seizures and Anitiepileptic Therapy on Rehabilitation Course of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05823168
- Acronym / sponsor ID
- 2503
- Conditions
- Seizures, Traumatic Brain Injury
- Keywords
- rehabilitation, outcome, prophylaptic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with seizures | – | Drug: Antiepileptic Drugpatients with traumatic brain injury |
| patients without seizures | – | Drug: Antiepileptic Drugpatients with traumatic brain injury |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiepileptic DrugAlso: antiepileptic prophylactic therapywe osberve the efficacy of antiepileptic drungs on preventing seizures and their impact on rehabilitation outcome | Drug | patients with seizures, patients without seizures |
Primary outcome
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.
1 secondary outcome
antiepileptic drugs and rehabilitation
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 38587858Pease 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.
- Individual participant dataSharing planned: No
Related trials for Seizures
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Traumatic Brain Injury, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure and rehabilitation (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.