ReACT for Nonepileptic Seizures

(ReACT Trial)

Overseen By Stephanie Mueller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Epilepsy, Intellectual disability, Mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how ReTraining and Control Therapy (ReACT) can assist individuals with psychogenic non-epileptic seizures (PNES), which resemble seizures but do not result from electrical brain activity. The research focuses on altering behaviors and thoughts to enhance participants' perceived control over their actions and manage symptom expectations. Participants will be randomly assigned to begin the therapy immediately or after a delay of 3 or 6 months. This trial may suit adults treated at the UAB FND clinic who have PNES and experience at least four episodes monthly. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve future treatment options for PNES.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ReTraining and Control Therapy (ReACT) is safe for treating psychogenic non-epileptic seizures?

Research has shown that Retraining and Control Therapy (ReACT) is a well-tolerated treatment for people with psychogenic non-epileptic seizures (PNES). Studies have found that ReACT can significantly reduce seizure frequency and improve overall management.

No major reports of serious side effects have emerged, indicating that ReACT is safe for participants. This therapy changes behaviors and thoughts, eliminating the need for medication. Consequently, it carries a lower risk of side effects commonly associated with drug treatments.

Overall, ReACT appears to be a promising and safe option for those with PNES, with studies supporting its positive effect on reducing seizures without major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ReTraining and Control Therapy (ReACT) for nonepileptic seizures because it offers a novel approach by focusing on retraining the brain's response to stress rather than relying solely on medication. Most current treatments for nonepileptic seizures, like cognitive behavioral therapy, aim to address underlying psychological factors, but ReACT takes it a step further by directly targeting the neurological patterns associated with stress responses. The therapy's potential to quickly modify these patterns could lead to faster and more effective management of symptoms, setting it apart from traditional methods.

What evidence suggests that ReTraining and Control Therapy (ReACT) could be an effective treatment for psychogenic non-epileptic seizures?

Research has shown that Retraining and Control Therapy (ReACT) may help treat psychogenic non-epileptic seizures (PNES). In earlier studies, ReACT reduced seizure frequency by focusing on changing thoughts and behaviors. Early results suggest that patients experienced fewer seizures and felt more in control of their actions after treatment. One study found these improvements lasted for at least a year, indicating long-term benefits. While most data is available for children, researchers are now adapting this approach for adults with PNES. Participants in this trial will be randomized to receive ReACT either immediately, after a 3-month waiting period, or after a 6-month waiting period. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron Fobian, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with psychogenic non-epileptic seizures (PNES), which look like epileptic seizures but aren't. Participants must be treated at the UAB FND clinic and willing to undergo twelve sessions of ReACT therapy, with some waiting up to 6 months before starting treatment.

Inclusion Criteria

I am 19 years old or older.

My seizures have been diagnosed as non-epileptic by a doctor using a video-EEG.

Exclusion Criteria

I have epilepsy.

I experience sudden episodes not caused by epilepsy, such as those related to sleep issues or migraines.

I experience fewer than 4 psychogenic non-epileptic seizures (PNES) a month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete several questionnaires assessing demographics, mood, suicidality, and PNES symptoms. Saliva samples are collected, and sleep and PNES episode severity and frequency are tracked.

1 week

1 visit (in-person)

Waiting Period

Participants are randomized to a waiting period of either 0, 3, or 6 months before starting therapy. During this time, they log weekly PNES episodes.

0-6 months

Treatment

Participants receive 12 sessions of Retraining and Control Therapy (ReACT) via telehealth. Therapy sessions focus on changing behaviors and thoughts related to PNES.

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up assessments occur at 7 days, 2 months, 6 months, and 12 months after the 12th treatment session.

12 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ReTraining and Control Therapy (ReACT)

Trial Overview

The study tests if ReACT, a behavior and thought-changing intervention, can improve control over actions and reduce catastrophic symptom expectations in PNES patients. It involves tasks measuring sense of control and responses to simulated stress (holding hand in cool water).

How Is the Trial Designed?

Group I: 3-month waiting period Active Control 1 Intervention

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 3 months.

Group II: No waiting period Active Control 1 Intervention

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) with no waiting period.

Group III: 6-month waiting period Active Control 1 Intervention

At the end of the baseline visit, participants will be randomized to receive Retraining and Control Therapy (ReACT) after a waiting period of 6 months.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The primary treatment goal for nonepileptic seizures (NES) is to improve quality of life by reducing seizure frequency through a combination of education, mental health support, and gradual weaning off anticonvulsants.

With appropriate diagnosis and treatment, approximately 45% of NES patients can become seizure-free, and an additional one-third may experience a reduction in seizure frequency, highlighting the effectiveness of integrated psychiatric care alongside psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonepileptic Seizures. Bowman, ES.[2020]

A specialized clinic for treating nonepileptic seizures (NES) was established, combining neurology and psychiatry services, and successfully treated 106 patients with a high retention rate of 65.4% after referral and 84.0% adherence to group therapy.

The clinic model not only provided effective psychological care but also led to a decrease in healthcare utilization, indicating its potential to improve access to care for both NES and epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a multidisciplinary group therapy clinic for the treatment of nonepileptic seizures. Libbon, R., Gadbaw, J., Watson, M., et al.[2020]

Cognitive behavioral therapy (CBT) has shown efficacy in treating psychogenic nonepileptic seizures (PNES), with evidence from a pilot randomized controlled trial indicating it is more effective than standard medical care.

While the antidepressant sertraline did not significantly reduce seizure frequency compared to placebo, it did lead to a notable decrease in symptoms from pre- to post-treatment, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychogenic nonepileptic seizures: a treatment review. What have we learned since the beginning of the millennium? Baslet, G.[2021]

In a study of 147 patients with psychogenic nonepileptic seizures (PNESs) followed for an average of 4.2 years, 28.6% achieved seizure remission, but nearly half of those remained unproductive, indicating that seizure control alone does not guarantee overall well-being.

Patients who stopped having seizures still reported significant ongoing psychological issues, suggesting that treatment for PNESs should address both seizure management and mental health to improve overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring outcome in psychogenic nonepileptic seizures: how relevant is seizure remission? Reuber, M., Mitchell, AJ., Howlett, S., et al.[2019]

In a study of 137 patients with various genetic epilepsies, perampanel showed a high responder rate of 71%, with an average seizure frequency reduction of 56.61%, indicating its efficacy as a treatment option.

Particularly effective in patients with specific genetic mutations like SCN1A and GNAO1, perampanel achieved over 90% seizure reduction in 27.5% of participants, suggesting a targeted mechanism of action related to glutamate transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perampanel as precision therapy in rare genetic epilepsies. Nissenkorn, A., Kluger, G., Schubert-Bast, S., et al.[2023]

Psychogenic nonepileptic seizures (PNES) are classified as a conversion disorder and require interdisciplinary management that focuses on modifiable risk factors, with patient engagement being a critical but challenging first step.

Cognitive-behavioral therapy has shown promise in treating PNES, and a preliminary study of mindfulness-based psychotherapy in 6 patients suggests it is feasible and should be explored further in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of psychogenic nonepileptic seizures: updated review and findings from a mindfulness-based intervention case series. Baslet, G., Dworetzky, B., Perez, DL., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7448150/

Retraining and control therapy for pediatric psychogenic ...

Comorbid diagnosis of epilepsy was acceptable as long as the patient's neurologist confirmed epileptic seizures were controlled (seizure‐free ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589986421000770

One-year follow-up of treatment outcomes and patient ...

This study aims to assess seizure frequency 1 year after ReACT and determine patient and parents' opinions of ReACT. Children with functional seizures who ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02801136?cond=Non-Epileptic%20Seizures&viewType=Table&rank=6

NCT02801136 | Treatment Outcomes of ReACT for PNES

Diagnosis of epilepsy is acceptable as long as patient's neurologist confirms that epileptic seizures are currently under control. Healthy controls are matched ...

4.

seizure-journal.com

seizure-journal.com/article/S1059-1311(21)00314-9/fulltext

Retraining and Control Therapy (ReACT) is a bottom-up ...

1. Velani DH, Gledhill DJ The effectiveness of psychological interventions for children and adolescents with non-epileptic seizures. Seizure, in ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06570954

Retraining and Control Therapy (ReACT)- Adults

Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG. Exclusion Criteria: Comorbid Epilepsy; Less than 4 PNES per month; Other ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1525505023000343

Patients with psychogenic nonepileptic seizures and ...

... outcome of patients with psychogenic nonepileptic seizures after diagnosis in an epilepsy ... Psychogenic non-epileptic seizures with and without epilepsy: ...

7.

withpower.com

withpower.com/trial/phase-seizures-11-2023-02a48

ReACT for Nonepileptic Seizures (ReACT Trial)

Research shows that Retraining and Control Therapy (ReACT) significantly reduces seizure frequency in children with functional seizures, with improvements ...

8.

epilepsy.com

epilepsy.com/diagnosis/imitators-epilepsy/psychogenic-nonepileptic-seizures

Psychogenic Nonepileptic Seizures (PNES)

What Is Epilepsy? ... Who Can Get Epilepsy? What Happens During a Seizure? How Serious Are Seizures? What Are the Risk Factors of Seizures? Will You Always Have ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10899437/

Outcome of psychogenic non-epileptic seizures following ...

To study the outcome of patients with psychogenic non-epileptic seizures (PNES) after their diagnosis in the epilepsy monitoring unit (EMU).