Neurobehavioral Therapy for Conversion Disorder

(NBT for mFND Trial)

Overseen By Deepica Clinical Research Program Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Self-injury, Suicidality, Psychosis, Substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 12-18 weeks

40 Participants Needed

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.

Research Team

W. Curt LaFrance Jr, MD, MPH

Principal Investigator

Brown University Health

Emily Weisbach, MD

Principal Investigator

Brown University Health

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 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)

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)

Treatment Details

Interventions

• Neuro-behavioral Therapy

Trial Overview 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.

Participant Groups

Group I: Neuro-Behavioral Therapy Experimental Treatment 1 Intervention

Participants will receive neuro-behavioral therapy (NBT), in individual, weekly, one-hour appointments, using the 12 session, "Taking Control of Your Functional Movements: Workbook", over the course of 12 to 18 weeks. Before each appointment, participants will complete worksheets/questions in one chapter that will be discussed during the weekly virtual appointment. Video appointments will be completed using an encrypted healthcare weblink and will be digitally recorded for review to ensure therapy adherence and competence. Participants randomized to the NBT arm will also participate in 5 in-person visits for exam documentation.

Group II: Standard Medical Care Active Control 1 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 the SMC arm will participate in 5 in-person visits for exam and SMC documentation.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+