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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 belowSelect...
I have epilepsy caused by a past injury, confirmed by a doctor or EEG.
Select...
My epilepsy started after a traumatic brain injury.
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I have moderate to severe anxiety or depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3, and month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, and month 6
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 moreOther outcome measures
AIM-Neurologist Perspective
Acceptability of Intervention Measure (AIM)-Subject Perspective
Change in BAI Score
+19 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have epilepsy caused by a past injury, confirmed by a doctor or EEG.I have difficulty understanding or completing mental health questionnaires.I am currently seeing a psychiatrist for treatment.My epilepsy started after a traumatic brain injury.I am currently having thoughts about harming myself.I do not have any worsening health conditions.I have moderate to severe anxiety or depression.I have moderate to severe anxiety or depression.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Collaborative Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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