What is the mechanism of action of this treatment?

The most common treatments for Post-Traumatic Epilepsy (PTE) include antiseizure medications and collaborative care approaches. Antiseizure medications, such as carbamazepine, lamotrigine, and levetiracetam, work by stabilizing neuronal membranes and reducing neuronal excitability, thereby preventing seizures. Collaborative care involves structured, regular support and guidance from healthcare providers to address the psychological and social impacts of PTE, such as anxiety and depression. This combined approach can lead to better overall management of the condition and improved quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for Post-Traumatic Epilepsy (PTE) include antiepileptic drugs (AEDs) such as phenytoin, carbamazepine, levetiracetam, and valproate. Known side effects of these medications can vary but often include dizziness, fatigue, nausea, and cognitive impairments. Phenytoin and carbamazepine may cause rash and liver enzyme elevation, while levetiracetam is associated with mood changes and irritability. Valproate can lead to weight gain, hair loss, and tremors. Collaborative care approaches, which provide structured support and guidance, aim to improve quality of life and may help manage these side effects by offering regular monitoring and personalized adjustments to treatment plans.

What prior FDA approvals exist?

The FDA has approved several antiepileptic drugs (AEDs) for the treatment of epilepsy, which can be used in cases of Post-Traumatic Epilepsy (PTE). These include medications like levetiracetam, lamotrigine, and valproate, which have shown efficacy in controlling seizures. While the focus of the Collaborative Care Calls trial is on structured, regular support to improve quality of life, there is limited specific FDA approval for such non-pharmacological interventions in PTE. However, collaborative care models, which involve regular follow-ups and support, have been studied in other contexts and shown to improve patient outcomes by providing comprehensive management beyond just medication.

What other types of research exist?

Promising novel alternatives to Collaborative Care Calls for Post-Traumatic Epilepsy patients include: 1) Seizure forecasting devices using digital markers, wearables, and biosensors to predict and manage seizures; 2) Nonpharmacological strategies such as stress-based and arousal-based techniques to increase perceived self-control and potentially reduce seizure frequency; 3) Advanced antiepileptic drugs with improved efficacy and safety profiles; 4) Surgical interventions like stereo-electroencephalography (SEEG) for precise seizure localization and treatment; 5) Psilocybin-assisted psychotherapy for addressing psychiatric and existential distress associated with epilepsy.

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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

Must not have

Cognitive limitations precluding completion of anxiety and depression self-report instruments

Active ongoing treatment by a psychiatrist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, and month 6

Awards & highlights

Summary

This trial is testing whether regular phone calls from a healthcare team can improve the quality of life for adults with post-traumatic epilepsy and anxiety or depression. The study will observe the effects over several 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty understanding or completing mental health questionnaires.

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I am currently seeing a psychiatrist for treatment.

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I am currently having thoughts about harming myself.

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I do not have any worsening health conditions.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)

Secondary study objectives

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 study objectives

AIM-Neurologist Perspective

Acceptability of Intervention Measure (AIM)-Subject Perspective

Change in BAI Score

+18 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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Post-Traumatic Epilepsy (PTE) include antiseizure medications and collaborative care approaches. Antiseizure medications, such as carbamazepine, lamotrigine, and levetiracetam, work by stabilizing neuronal membranes and reducing neuronal excitability, thereby preventing seizures. Collaborative care involves structured, regular support and guidance from healthcare providers to address the psychological and social impacts of PTE, such as anxiety and depression. This combined approach can lead to better overall management of the condition and improved quality of life for patients.