NCT05353452 Collaborative Care in Posttraumatic Epilepsy
| NCT ID | NCT05353452 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Epilepsy, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-04-30 |
| Primary Completion | 2026-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2023-04-30 with a primary completion date of 2026-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures * Diagnosis of post-traumatic epilepsy, defined by the following: 1. Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis) 2. History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database 3. TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form) * Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) \>13 * Receiving clinical neurological care at one of the study sites Exclusion Criteria: * Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators * Active suicidal ideation * History of past suicide attempt * Unstable drug or alcohol abuse * Unstable or progressive comorbid medical condition * Current participation in another treatment or intervention study * Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
Contact & Investigator
Heidi M. Munger Clary, MD, MPH
PRINCIPAL INVESTIGATOR
Atrium Health Wake Forest Baptist
Frequently Asked Questions
Who can join the NCT05353452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05353452 currently recruiting?
Yes, NCT05353452 is actively recruiting participants. Contact the research team at hmungerc@wakehealth.edu for enrollment information.
Where is the NCT05353452 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05353452 clinical trial?
NCT05353452 is sponsored by Wake Forest University Health Sciences. The principal investigator is Heidi M. Munger Clary, MD, MPH at Atrium Health Wake Forest Baptist. The trial plans to enroll 56 participants.
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