Traumatic Brain InjuryNCT05517954
Cortical Excitability in Post-traumatic Epilepsy
An observational study of Traumatic Brain Injury and Cortical Excitability, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
Trial summary
To test whether measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls and whether such measures can be used to distinguish patients with post-traumatic epilepsy from… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cortical Excitability, Epilepsy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Aug 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from the site's database, plus 10 healthy volunteers
Who may be able to join
- Group 1 (N=10):
- Age 18-70
- Sex: male/female
- PTE, defined as acquired epilepsy with seizures that developed within ten years of TBI with no other clear cause
- Stable ASM doses for at least 30 days
- Epilepsy duration for ≥ 6 months
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- Group 2 (N=10):
- Age 18-70
- Sex: male/female
- Absent epilepsy, but TBI in the past two years and any of the following:
- Multifocal intracerebral hemorrhages (ICH)
- depressed skull fracture
- Subdural hematoma (SDH) requiring surgery
- SDH and ICH
- Penetrating wound
- Group 3 (N=10):
- Age 18-70
- Sex: male/female
- Absent epilepsy or TBI
Who cannot join
- Primary generalized epilepsy
- Non-epileptic seizures
- Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
- Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
- Change in dose of any antiseizure medication within 30 days prior to enrollment
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators that would interfere with adherence to study requirements;
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- Use of any CNS-active investigational drugs within 1 month of enrollment.
- Resective epilepsy surgery less than 6 months before study initiation.
- Implanted electrical device (e.g. vagal nerve stimulator, deep brain stimulator, responsive neurostimulation device, cardiac pacemeaker, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mid-Atlantic Epilepsy and Sleep center
Bethesda, Maryland, 20817
Ivana Tyrlikova, 301-530-9744, tyrlikovai@epilepsydc.com
Pavel Klein, MD, 3015309744, kleinp@epilepsydc.com
About this study
Official title: Measures of Cortical Excitability in Patients With Post-traumatic Epilepsy, Traumatic Brain Injury Patients Without Epilepsy, and Healthy Controls: a Pilot Study
To test whether measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls and whether such measures can be used to distinguish patients with post-traumatic epilepsy from patients with head trauma but no epilepsy
Read the detailed description
This is a pilot a pilot cross-sectional study to evaluate the utility of TMS-derived biomarkers in PTE prediction and detection. We will measure motor cortex excitability and intracortical inhibition (see below) in TBI patients with PTE (Group 1), TBI patients with average 30% risk of developing PTE who have not yet developed PTE (Group 2) and healthy age- and sex-matched control participants (group 3). 10 adult subjects aged 18-70 will be recruited into each group. We shall obtain a range of TMS metrics in each individual (see below), and, per metric, compare average values among groups by 1-way ANOVA. Our specific hypothesis is that, relative to healthy control, motor cortex TMS measures will indicate increased cortical excitability in participants with PTE, and a trend toward same in patients with TBI who have not developed PTE For subjects in groups 2 and 3, all antiseizure treatments will be stable (unchanged) for 4 weeks prior to evaluation. Subjects will undergo two ppTMS testing separated by 1-2 weeks. Per participant, TMS metrics (see below), will be evaluated for test-retest reliability (our secondary outcome measure)
- Conditions
- Traumatic Brain Injury, Cortical Excitability, Epilepsy
- Medical subject headings
- Brain Injuries, Traumatic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with TBI and PTE | 10 subjects with a history of TBI, diagnosed with PTE (post-traumatic epilepsy). PTE is defined as acquired epilepsy with seizures that developed within ten years of TBI with no other clear cause | |
| Subjects with TBI, no PTE | 10 subjects with a history of TBI, and absent epilepsy, but TBI in the past two years and any of the following: * Multifocal intracerebral hemorrhages (ICH) * depressed skull fracture * Subdural hematoma (SDH) requiring surgery * SDH and ICH * Penetrating wound | |
| Healthy volunteers | 10 healthy volunteers; absent epilepsy or TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the cortical excitability in subjects with TBI, TBI with PTE, subjects without TBI and epilepsy
Measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls, and whether such measures can be used to distinguish patients with post-traumatic epilepsy from patients with head trauma but no epilepsy.
Measured: 2-10 years after TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Alexander Rotenberg, M.D., Ph.D
- Responsible party
- Principal investigator, Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517954
- Sponsor's protocol ID
- maesc011
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measures of Cortical Excitability in Patients With Post-traumatic Epilepsy, Traumatic Brain Injury Patients Without Epilepsy, and Healthy Controls: a Pilot Study
- ClinicalTrials.gov ID
- NCT05517954
- Acronym / sponsor ID
- maesc011
- Conditions
- Traumatic Brain Injury, Cortical Excitability, Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLCUniversity, hospital or other
- Collaborators
- Alexander Rotenberg, M.D., Ph.D
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 26 Aug 2022 (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.
To test whether measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls and whether such measures can be used to distinguish patients with post-traumatic epilepsy from patients with head trauma but no epilepsy
Detailed description
This is a pilot a pilot cross-sectional study to evaluate the utility of TMS-derived biomarkers in PTE prediction and detection. We will measure motor cortex excitability and intracortical inhibition (see below) in TBI patients with PTE (Group 1), TBI patients with average 30% risk of developing PTE who have not yet developed PTE (Group 2) and healthy age- and sex-matched control participants (group 3). 10 adult subjects aged 18-70 will be recruited into each group. We shall obtain a range of TMS metrics in each individual (see below), and, per metric, compare average values among groups by 1-way ANOVA. Our specific hypothesis is that, relative to healthy control, motor cortex TMS measures will indicate increased cortical excitability in participants with PTE, and a trend toward same in patients with TBI who have not developed PTE For subjects in groups 2 and 3, all antiseizure treatments will be stable (unchanged) for 4 weeks prior to evaluation. Subjects will undergo two ppTMS testing separated by 1-2 weeks. Per participant, TMS metrics (see below), will be evaluated for test-retest reliability (our secondary outcome measure)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with TBI and PTE | – | –10 subjects with a history of TBI, diagnosed with PTE (post-traumatic epilepsy). PTE is defined as acquired epilepsy with seizures that developed within ten years of TBI with no other clear cause |
| Subjects with TBI, no PTE | – | –10 subjects with a history of TBI, and absent epilepsy, but TBI in the past two years and any of the following: * Multifocal intracerebral hemorrhages (ICH) * depressed skull fracture * Subdural hematoma (SDH) requiring surgery * SDH and ICH * Penetrating wound |
| Healthy volunteers | – | –10 healthy volunteers; absent epilepsy or TBI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the site's database, plus 10 healthy volunteers
Key inclusion criteria (19 listed)
- Age 18-70
- Sex: male/female
- PTE, defined as acquired epilepsy with seizures that developed within ten years of TBI with no other clear cause
- Stable ASM doses for at least 30 days
- Epilepsy duration for ≥ 6 months
Key exclusion criteria (9 listed)
- Primary generalized epilepsy
- Non-epileptic seizures
- Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
- Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
- Change in dose of any antiseizure medication within 30 days prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the cortical excitability in subjects with TBI, TBI with PTE, subjects without TBI and epilepsy
Time frame: 2-10 years after TBI
Measures of cortical excitability derived from motor cortex transcranial magnetic stimulation (TMS) in patients with traumatic brain injury reflect heightened excitability relative to healthy controls, and whether such measures can be used to distinguish patients with post-traumatic epilepsy from patients with head trauma but no epilepsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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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.
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 Traumatic Brain Injury and Cortical Excitability, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
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 19 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivana Tyrlikova (3015309744, tyrlikovai@epilepsydc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the cortical excitability in subjects with TBI, TBI with PTE, subjects without TBI and epilepsy (time frame: 2-10 years after TBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2022.