Cortical Excitability in Post-traumatic Epilepsy

NCT05517954 | Unknown

• 1 other identifier: maesc011
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury; Cortical Excitability; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  2-10 years after TBI

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.)

Sponsors & Collaborators

• Mid-Atlantic Epilepsy and Sleep Center, LLC: lead
• Alexander Rotenberg, M.D., Ph.D: collaborator

Study Sites (1)

Mid-Atlantic Epilepsy and Sleep center

Bethesda, Maryland, 20817, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Epilepsy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ivana Tyrlikova

CONTACT

3015309744; tyrlikovai@epilepsydc.com

Pavel Klein, MD

CONTACT

3015309744; kleinp@epilepsydc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pavel Klein, MD

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)