What side effects are associated with this type of intervention?

Behavioral interventions for Nonepileptic Seizures, such as Retraining and Control Therapy (ReACT) and Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT), generally have minimal physical side effects compared to pharmacological treatments. However, patients may experience psychological discomfort, increased anxiety, or emotional distress as they confront and work through the underlying issues triggering their seizures. Additionally, adherence to the therapy regimen can be challenging, and there may be variability in the effectiveness of the treatment based on individual patient factors.

What prior FDA approvals exist?

There are no FDA-approved pharmacological treatments specifically for Nonepileptic Seizures (PNES). The primary approach to managing PNES involves psychological and behavioral therapies, such as Cognitive Behavioral Therapy (CBT) and other psychotherapeutic interventions. These therapies aim to address the underlying psychological factors contributing to the seizures. Retraining and Control Therapy (ReACT), being studied in the trial, is a behavioral intervention designed to help patients retrain and control their responses to functional seizures, aligning with the standard non-pharmacological treatment approach for PNES.

What other types of research exist?

Promising novel alternatives to ReACT for Nonepileptic Seizures patients include: 1) Cognitive Behavioral Therapy (CBT) tailored for NES, which focuses on identifying and changing negative thought patterns and behaviors. 2) Mindfulness-Based Stress Reduction (MBSR), which helps patients manage stress and improve emotional regulation. 3) Neurofeedback, a technique that trains patients to control brain activity and has shown efficacy in other neurological conditions. 4) Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation method that has potential in modulating neural circuits involved in NES. 5) Integrative approaches combining psychotherapy with physical therapies such as yoga or tai chi, which promote overall well-being and stress management.

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ReACT for Functional Seizures

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of functional seizures

Males and females ages 11-18

Must not have

Severe intellectual disability

Comorbid epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 to 7 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two treatments for young people aged 11-18 who experience seizures. One treatment involves therapy sessions to manage seizures, while the other uses online lessons and coaching to change behaviors. The goal is to see which method works better for these patients.

Who is the study for?

This trial is for boys and girls aged 11-18 with a diagnosis of functional seizures. They must have internet access for telehealth sessions. Those with comorbid epilepsy, less than four seizures per month, severe intellectual disability, involvement in other therapies or severe mental illness are excluded.

What is being tested?

The study compares two treatments: Retraining and Control Therapy (ReACT) and CATCH-IT to see which helps manage pediatric functional seizures better. Participants will be randomly assigned to one of the treatments at three different sites over an 18-month period.

What are the potential side effects?

Since ReACT and CATCH-IT involve behavioral therapy rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort or stress during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with functional seizures.

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I am between 11 and 18 years old.

Exclusion Criteria

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

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I have a severe intellectual disability.

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I have epilepsy in addition to my primary condition.

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I experience fewer than 4 seizures a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 to 7 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of Recruitment

Participant Adherence

Treatment Fidelity

Secondary study objectives

Acceptability

Anxiety Sensitivity Index (ASI)

Beaver's Self-Report Family Inventory

+24 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ReACT InterventionExperimental Treatment1 Intervention

During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention. ReACT includes 12 sessions with a therapist that will discuss a plan for managing FS. Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.

Group II: CATCH-IT InterventionActive Control1 Intervention

During the initial visit participant will be randomized to either Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) intervention. CATCH-IT involves the parent and child completing CBT modules on the web-based CATCH-IT platform, and they will meet with a CATCH-IT coach 12 times to discuss the modules and plan how to apply this to their life and their FS. Participants will have 12 therapy sessions. The first session will be in-person which will last 2 hours and the subsequent 11 sessions will be conducted via video telehealth and each session will last 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ReACT

2016

N/A

~100

0 / 5Eligibility 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 Nonepileptic Seizures (NES) often involve behavioral interventions that focus on retraining and controlling responses to functional seizures. These treatments, such as Retraining and Control Therapy (ReACT), use cognitive-behavioral techniques to modify maladaptive thought patterns and behaviors, humanistic approaches to enhance self-awareness and emotional regulation, and interpersonal training to improve social interactions and support systems. This approach is crucial for NES patients as it addresses the underlying psychological factors that trigger seizures, leading to more effective and sustainable management of their condition.

Effect of cotherapy reduction on tolerability of epilepsy add-on therapy: a randomized controlled trial.A randomized, double-blinded, placebo-controlled trial of phenytoin for the prevention of early posttraumatic seizures in children with moderate to severe blunt head injury.