Cortical Excitability in Post-traumatic Epilepsy

NCT ID: NCT05517954

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-08-31

Brief 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 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)

Conditions

Traumatic Brain Injury; Cortical Excitability; Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Healthy volunteers

10 healthy volunteers; absent epilepsy or TBI

No interventions assigned to this group

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexander Rotenberg, M.D., Ph.D

UNKNOWN

Sponsor Role: collaborator

Mid-Atlantic Epilepsy and Sleep Center, LLC

OTHER

Sponsor Role: lead

Responsible Party

Pavel Klein

Pavel Klein, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mid-Atlantic Epilepsy and Sleep center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ivana Tyrlikova

Role: CONTACT

tyrlikovai@epilepsydc.com

3015309744

Pavel Klein, MD

Role: CONTACT

kleinp@epilepsydc.com

3015309744

Facility Contacts

Ivana Tyrlikova

Role: primary

tyrlikovai@epilepsydc.com

301-530-9744

Pavel Klein, MD

Role: backup

kleinp@epilepsydc.com

3015309744

Other Identifiers

maesc011

Identifier Type: -

Identifier Source: org_study_id