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Collaborative Care for Post-Traumatic Epilepsy

N/A
Recruiting
Led By Heidi M. Munger Clary, MD, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of post-traumatic epilepsy based on neurology clinician impression or EEG findings
TBI pre-dated onset of epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, and month 6
Awards & highlights

Study Summary

This trial will compare a 24-week neurology-based collaborative care program to usual neurology care among adults with post-traumatic epilepsy, measuring quality of life after 6 months.

Who is the study for?
This trial is for adults with post-traumatic epilepsy who have had a traumatic brain injury and are experiencing anxiety or depression. They must be getting care at one of the study sites, agree to follow the study rules, and not be in another treatment study. People with unstable substance abuse, severe other illnesses, cognitive issues affecting survey completion, psychiatric treatment, or serious suicidal thoughts can't join.Check my eligibility
What is being tested?
The trial is testing if special collaborative care calls over 6 months improve life quality compared to usual neurology care for people with post-traumatic epilepsy. It's conducted at two locations and involves 60 participants comparing two types of neurological support.See study design
What are the potential side effects?
Since this trial compares different types of care rather than medications, it does not list specific side effects like drug trials do. However, any changes in mental health due to the nature of support received will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have epilepsy caused by a past injury, confirmed by a doctor or EEG.
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My epilepsy started after a traumatic brain injury.
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I have moderate to severe anxiety or depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
Secondary outcome measures
Change in Beck Anxiety Index (BAI) score
Change in Beck Depression Inventory-II (BDI-II) score
Change in Epilepsy specific QOLIE-31 score
+1 more
Other outcome measures
AIM-Neurologist Perspective
Acceptability of Intervention Measure (AIM)-Subject Perspective
Change in BAI Score
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborative CareExperimental Treatment1 Intervention
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,234 Previous Clinical Trials
1,001,997 Total Patients Enrolled
Heidi M. Munger Clary, MD, MPHPrincipal InvestigatorAtrium Health Wake Forest Baptist
2 Previous Clinical Trials
910 Total Patients Enrolled

Media Library

Neurology Based Collaborative Care Clinical Trial Eligibility Overview. Trial Name: NCT05353452 — N/A
Post-Traumatic Epilepsy Research Study Groups: Standard of Care (SOC), Collaborative Care
Post-Traumatic Epilepsy Clinical Trial 2023: Neurology Based Collaborative Care Highlights & Side Effects. Trial Name: NCT05353452 — N/A
Neurology Based Collaborative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353452 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants in this clinical experiment?

"The information on clinicaltrials.gov reveals that, as of September 26th 2022, this particular trial has ceased recruiting patients for participation. Despite this, there are still 239 other studies actively recruiting individuals at the present time."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~35 spots leftby Jul 2025