ClinConnect ClinConnect Logo
Search / Trial NCT05353452

Collaborative Care in Posttraumatic Epilepsy

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 25, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Epilepsy Neurological Care Collaborative Care Anxiety Depression

ClinConnect Summary

This clinical trial is looking at how a special type of care can improve the quality of life for adults with post-traumatic epilepsy, which is a type of epilepsy that happens after a head injury. Over six months, participants will receive either usual care from their neurologist or a collaborative care program that includes regular support calls from a healthcare team. The study aims to involve 60 adults aged between 65 and 74, who have been diagnosed with post-traumatic epilepsy and also experience symptoms of anxiety or depression.

To participate, individuals need to agree to join the study and have a history of mild traumatic brain injury that happened before their epilepsy started. They should also be receiving care from one of the study sites. Those with serious mental health issues, such as active suicidal thoughts or severe substance abuse, are not eligible. Participants can expect regular check-ins and support if they are in the collaborative care group, while those receiving usual care will continue with their regular neurologist appointments. This study aims to see if the extra support can make a difference in their daily lives and overall well-being.

Gender

ALL

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.

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Heidi M. Munger Clary, MD, MPH

Principal Investigator

Atrium Health Wake Forest Baptist

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials