Pilot Neurobehavioral Therapy for Functional Neurological Disorder (NBT for mFND)

July 7, 2026 updated by: W. Curt LaFrance Jr., MD, MPH, Rhode Island Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to enroll 40 participants at Rhode Island Hospital. 20 participants with Motor Functional Neurological Disorder (mFND) will be randomized to Neurobehavioral Therapy (Group 1) and 20 participants with mFND to Standard Medical Care (Group 2). Those randomized to neurobehavioral therapy will be asked to complete treatment sessions over the course of 12 to 18 weeks. Those in the standard medical care arm will continue to receive their routine care with their clinicians.

All participants regardless of group assignment, will complete a total of five in-person clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months. These visits will include the completion of interview questions and self-report surveys that will assess functional status, quality of life and mFND symptoms.

Please see the "Arms and Interventions" section to see a more detailed description of each group/arm.

The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 100 diagnosed with Motor Functional Neurologic Disorder. The main questions this study aims to answer are:

Aim 1: Examine the feasibility, acceptability, and practicality of manualized Neuro-Behavioral Therapy (NBT) in Functional Neurological Disorder (FND).

Hypothesis 1: Manualized NBT will demonstrate feasibility through acceptability and practicality, defined as ≥80% of participants enrolling in the study will participate in the study measures (acceptability) and complete the entire study protocol (practicality), respectively.

Aim 2: Examine the preliminary effectiveness of manualized NBT in improving health-related quality of life and reducing the severity and disability of mFNDs, as measured by the SF-36 and PMDRS/S-FMDRS (primary outcome), respectively.

Hypothesis 2: NBT will show improvements in SF-36 scores and reductions in PMDRS scores. We will evaluate this by conducting a preliminary examination of the manualized NBT intervention, with a focus on interpreting effect sizes. We will also gather key statistics needed to inform a fully powered clinical trial, such as the standard deviation and pre-post correlation of the SF-36 and PMDRS.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
  • Individuals aged 18-100 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Neuro-behavioral Therapy
Neuro-behavioral therapy (NBT) is an evidence-based, multi-modality, time-limited, whole-person therapy, delivered in one hour, weekly, individual appointments. NBT has been used to treat epilepsy, nonepileptic (functional) seizures, and motor functional neurological disorder (mFND).
Other Names:
  • Taking Control of Your Functional Motor Disorder Workbook
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.
Other: Standard Medical Care (SMC)
Standard Medical Care (SMC) involves the routine care received by the participant. SMC may include any of the following evaluation and followup appointments with neurology, physiatry, psychiatry, psychology, mental health, rehabilitation (e.g., Physical Therapy, Occupational Therapy, Speech and Language Therapy), primary care, among other specialists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 Health Survey (SF-36)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The SF-36 is a 36-item self-report measure that assess 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Psychogenic Movement Disorders Rating Scale (PMDRS)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The PMDRS is a clinical assessment tool designed to measure the severity and characteristics of abnormal movements associated with psychogenic movement disorders (also called functional movement disorders), including details like the type of movement, affected body regions, duration, and functional impact of the symptoms, allowing clinicians to track changes over time and evaluate treatment efficacy.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The S-FMDRS is a clinical tool used to assess the severity of functional movement disorders (FMDs) by evaluating the presence and intensity of abnormal movements in different body regions, including gait and speech.
Baseline, Week 6, Week 12, 8 Months and 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The GAD-7 is a 7 item self-report measure that assesses Anxiety severity from "0" (not at all) to "3" (nearly every day) on each question. The highest possible score is "21", relating to the highest severity of Generalized Anxiety Disorder.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The PHQ-9 is a 9-item self-report measure instrument that assesses the severity of Depression on a scale from "0" (not at all) to "3" (nearly every day). The maximum score is 27.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Posttraumatic Scale Checklist-5 (PCL-5)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Global Assessment of Functioning (GAF)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning and symptoms of an individual during a specified time period on a continuum from psychological or psychiatric sickness to health.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Severity (CGI-S)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal ("1") to among the most extremely ill patients ("7"). A higher score relates to a higher severity of illness.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Improvement (CGI-I)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved ("1") to very much worse ("7"). A lower score represents a higher improvement.
Baseline, Week 6, Week 12, 8 Months and 12 Months
World Health Organization: Quality of Life - BREF (WHOQOL-BREF)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
This is a 27-item self-report scale to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The PROMIS 29+2 v.2.1 is a 29 item self-report measure that assesses seven key health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Multidimensional Health Locus of Control (MHLC-C)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The MHLC-C is a 18 item self-report measure that assesses how individuals view control over their health when dealing with a specific condition. It looks at three beliefs: (1) whether individuals feel in control of their health (Internal), (2) whether individuals rely on doctors or others (Powerful Others), or (3) whether individuals think health is mostly luck or chance (Chance). This survey helps to understand how these three beliefs may influence how individuals manage their condition.
Baseline, Week 6, Week 12, 8 Months and 12 Months
Traumatic Life Events Questionnaire (TLEQ)
Time Frame: Baseline
The TLEQ is a 17-item self-report measure that assesses individuals experiences with potentially traumatic events, such as accidents, natural disasters, or violence. The TLEQ helps to identify whether someone has been exposed to trauma, how often these events have occurred and how impact or distressing these events were on ones well-being.
Baseline
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, Week 12, and 12 Months
The MoCA is a 30 item assessment tool used to detect mild cognitive impairment by evaluating various cognitive domains like memory, attention, language, visuospatial abilities, executive function, and orientation. The scale has a total possible score of 30 points, where a score of 26 or higher is typically considered normal while a lower score may indicate potential cognitive impairment.
Baseline, Week 12, and 12 Months
Patient Health Questionnaire (PHQ-15)
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The PHQ-15 is a 15-item self-report measure instrument that assesses the presence and severity of somatic symptoms on a scale from "0" (not bothered at all) to "2" (bothered a lot). The maximum score is 30.
Baseline, Week 6, Week 12, 8 Months and 12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal Movement Log
Time Frame: Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months
The Abnormal Movements Log is a daily diary to track unusual movements over the course of a week. Each day, individuals will record a series of details in relation to their mFND such as the number, duration, time, body parts affected, type of movement, severity (mild, moderate, severe), triggers, warning signs, what helps, and how it impacts themselves and others. The Principal Investigator will review the movement logs during study visits to better understand ones symptoms and how impactful they are one ones day. It's a simple tool aimed to identify patterns and improve care.
Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months
Status Survey
Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
The Status Survey is a 17 item self report measure that assesses research participants experience with motor Functional Neurological Disorder (FND) through the duration of the trial. The survey asks about current symptoms, emergency room visits, medications (for movement, anxiety, or depression), new therapies, and any new or worsening symptoms. It also includes questions about individuals daily life, such as work, disability status, driving, and overall quality of life over the past four weeks. The goal is to gather updates on how individuals are managing FND and its impact on ones well-being.
Baseline, Week 6, Week 12, 8 Months and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: W. Curt LaFrance Jr, MD, MPH, Brown University Health
  • Study Chair: Emily Weisbach, MD, Brown University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2136841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data used in the current study will be available after termination of the embargo period or upon reasonable request from the authors with regulatory approval.

IPD Sharing Time Frame

Data will be available after termination of the embargo period until IRB closure.

IPD Sharing Access Criteria

Data will be made available to authors with regulatory approval upon reasonable request to the study Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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