Pilot Neurobehavioral Therapy for Functional Neurological Disorder (NCT06873698) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Neurobehavioral Therapy for Functional Neurological Disorder
United States40 participantsStarted 2024-09-25
Plain-language summary
The goal of this pilot randomized clinical trial is to learn if Neurobehavioral Therapy (NBT) works to treat motor functional neurological disorder (mFND) (also referred to as functional motor disorder).
The main questions it aims to answer are:
* Does NBT lower mFND symptoms?
* Does NBT lower common co-occurring symptoms and improve functioning?
Researchers will compare NBT to standard medical care (SMC).
Participants will be randomized to receive either:
* 12 weekly sessions of NBT, along with their SMC,
* or continue receiving their SMC as provided by their treating clinicians.
* all participants. regardless of group assignment, will complete a total of five in-clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months for self-report surveys to assess functional status, quality of life and mFND symptoms.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
* Individuals aged 18-70 years
* At least 1 mFND symptom during the year prior to enrollment
Exclusion Criteria:
* Current or past year self-injurious behavior
* Current suicidality (PHQ-9 question 9 rated as 1 or above)
* Current or past year psychosis
* Pending litigation or current application for long term disability
* Active substance or alcohol use disorders (dependence), at the discretion of the investigator if they preclude participation in the study
* Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry
* Inability to fill out the self-report surveys
* Inability or unwillingness to participate in NBT and assigned homework
* Currently enrolled in NBT aimed at mFND
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.