Cortical Excitability in Post-traumatic Epilepsy

August 25, 2022 updated by: Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from the site's database, plus 10 healthy volunteers

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

  1. Primary generalized epilepsy
  2. Non-epileptic seizures
  3. Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
  4. 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
  5. Change in dose of any antiseizure medication within 30 days prior to enrollment
  6. 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;
  7. Use of any CNS-active investigational drugs within 1 month of enrollment.
  8. Resective epilepsy surgery less than 6 months before study initiation.
  9. Implanted electrical device (e.g. vagal nerve stimulator, deep brain stimulator, responsive neurostimulation device, cardiac pacemeaker, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2-10 years after TBI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mid-Atlantic Epilepsy and Sleep Center, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexander Rotenberg, M.D., Ph.D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • maesc011

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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