Neurobehavioral Therapy for Conversion Disorder
(NBT for mFND Trial)

Recruiting in Palo Alto (17 mi)

Overseen byW. Curt LaFrance Jr, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rhode Island Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 18 to 70 with Motor Functional Neurological Disorder (mFND), which includes symptoms like panic attacks and conversion disorder. Participants should be able to attend treatment sessions over several weeks and commit to five in-person clinic visits for assessments.

Inclusion Criteria

I have been diagnosed with Motor Functional Neurological Disorder.

I am between 18 and 70 years old.

I have experienced at least one symptom of functional neurological disorder in the last year.

Exclusion Criteria

I've been stable for 30 days after treatment for a serious illness.

Current or past year self-injurious behavior

Current suicidality (PHQ-9 question 9 rated as 1 or above)

+6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Neurobehavioral Therapy or Standard Medical Care. Neurobehavioral Therapy involves weekly one-hour sessions over 12 to 18 weeks, while Standard Medical Care involves routine care with clinicians.

12-18 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Baseline, 6 weeks, 12 weeks, 8 months, and 12 months.

12 months

5 visits (in-person)

Participant Groups

The study compares Neurobehavioral Therapy (NBT) against Standard Medical Care (SMC) in patients with mFND. It aims to determine if NBT can improve quality of life and reduce symptom severity, measured by SF-36 and PMDRS/S-FMDRS scales, through regular sessions over 12-18 weeks.

2Treatment groups

Experimental Treatment

Active Control

Group I: Neuro-Behavioral TherapyExperimental Treatment1 Intervention

Participants will complete neurobehavioral therapy with Dr. LaFrance, in individual, weekly, one-hour, appointments, using the workbook, "Taking Control of Your Functional Movements". Participants will review 12 chapters over the course of 12 to 18 weeks. Prior to each session, participants will review the workbook and complete worksheets/questions that will be discussed during the virtual appointment. Video sessions will be completed using an encrypted healthcare Zoom link and will be digitally recorded to ensure therapy adherence and competence. Subjects randomized to this group will also participate in 5 in-person visits.

Group II: Standard Medical CareActive Control1 Intervention

If randomized to this treatment arm, participants will continue to follow up with their clinicians while receiving standard medical care (SMC) and without receiving the study intervention. Research staff will ask about what care participants are receiving when they meet with staff. Subjects randomized to this group will participate in 5 in-person visits for exam and SMC documentation.