A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Individuals diagnosed with Motor Functional Neurological Disorder (mFND)

• Individuals aged 18-70 years

• At least 1 mFND symptom during the year prior to enrollment

Locations
United States
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Contact Information
Primary
Alexis Sr. Clinical Research Assistant
ademarco@brownhealth.org
401-606-4651
Backup
Deepica Clinical Research Program Coordinator
dchaudhary@brownhealth.org
401-606-4655
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2028-06
Participants
Target number of participants: 40
Treatments
Experimental: Neuro-Behavioral Therapy
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.
Active_comparator: Standard Medical Care
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.
Related Therapeutic Areas
Sponsors
Leads: Rhode Island Hospital

This content was sourced from clinicaltrials.gov