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Behavioural Intervention

ReACT for Nonepileptic Seizures (ReACT Trial)

N/A
Recruiting
Led By Aaron Fobian, PhD
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 psychogenic non-epileptic seizures by a medical doctor using video-EEG
11-18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 to 7 months
Awards & highlights

ReACT Trial Summary

This trial aims to test how to help kids w/ PNES (episodes resembling epileptic seizures) using a behavioral & thought intervention, & measure sense of control & catastrophic symptom expectations.

Who is the study for?
This trial is for young people aged 11-18 with a diagnosis of psychogenic non-epileptic seizures (PNES), confirmed by video-EEG. They must experience at least four PNES per month and have a family member willing to participate. Those with comorbid epilepsy, other nonepileptic events, severe intellectual disability or mental illness, or those in another therapy are excluded.Check my eligibility
What is being tested?
The study compares Retraining and Control Therapy (ReACT) against supportive therapy in managing PNES. Participants will undergo twelve sessions of their assigned treatment. The effectiveness is measured through sense of control tasks, pain tolerance tests like the cold pressor test, and stress responses before and after treatment as well as six months later.See study design
What are the potential side effects?
Since ReACT focuses on behavioral and thought changes without medication, side effects may be minimal but could include discomfort during the cold pressor test or emotional distress from confronting thoughts related to seizures.

ReACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My seizures have been diagnosed as non-epileptic by a doctor using video-EEG.
Select...
I am between 11 and 18 years old.

ReACT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magic and turbulence task
Pain Rating Scale
Pain catastrophizing scale for children- situation specific
+3 more
Secondary outcome measures
Anxiety Sensitivity Index (ASI)
Beaver's Self-Report Family Inventory
COVID-19 Functional Neurological Disorders (FND) Questionnaire
+35 more

ReACT Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ReACT InterventionExperimental Treatment1 Intervention
At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT)
Group II: Healthy ControlActive Control1 Intervention
Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.
Group III: Supportive TherapyActive Control1 Intervention
At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ReACT
2016
N/A
~100

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,502 Total Patients Enrolled
1 Trials studying Nonepileptic Seizures
224 Patients Enrolled for Nonepileptic Seizures
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,539 Total Patients Enrolled
Aaron Fobian, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
1,100 Total Patients Enrolled

Frequently Asked Questions

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

Are there any eligibility requirements for participation in this experiment?

"To qualify for this study, applicants must have non-epileptic seizures and be between 11 to 18 years old. Approximately 160 candidates are set to participate in the trial."

Answered by AI

Are recruitment efforts occurring for this experiment?

"The clinicaltrials.gov database shows that this research is not presently recruiting patients, despite its start date on December 1st 2023 and latest update of August 22nd 2023. However, there are over one hundred other studies actively seeking candidates at present."

Answered by AI

Are individuals of advanced age being considered as recruits for this clinical experiment?

"This clinical trial is specifically designed for patients aged 11 to 18. There are 42 trials available exclusively for minors and 71 studies catering to those 65 years old or older."

Answered by AI

What are the core goals of this medical experiment?

"The primary outcome this experiment seeks to measure over a 10-month period is salivary cortisol. Secondary objectives include the Pain Catastrophizing Scale for Children (PCS-C)- General, the Children's Somatic Symptoms Inventory (CSSI-24), and Anxiety Sensitivity Index (ASI). Each of these metrics will be assessed at baseline as well as 1 week, 6 months, and 12 months after completion of therapy sessions."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I’m suffering from PNES without any medication help. I am interested in seeing what this trial has to offer my PNES sessions I have almost daily. I’ve fallen off the roof of my house and falling is what keeps reeling through my head. Maybe some medicine can help with cutting down the daily occurrences.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Retraining and Control Therapy (ReACT) R33 Phase
Aaron Fobian 2024. "Retraining and Control Therapy (ReACT) R33 Phase". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007053.
~107 spots leftby Aug 2026
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