Epilepsy Clinical Trial
Official title:
Measures of Cortical Excitability in Patients With Post-traumatic Epilepsy, Traumatic Brain Injury Patients Without Epilepsy, and Healthy Controls: a Pilot Study
NCT number | NCT05517954 |
Other study ID # | maesc011 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | August 31, 2024 |
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
United States | Mid-Atlantic Epilepsy and Sleep center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Mid-Atlantic Epilepsy and Sleep Center, LLC | Alexander Rotenberg, M.D., Ph.D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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