An interventional study of Neuro-behavioral Therapy and Standard Medical Care (SMC) in Functional Neurological Disorder, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment
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:
Researchers will compare NBT to standard medical care (SMC).
Participants will be randomized to receive either:
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.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 40 is close to the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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)
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).
Also known as: Taking Control of Your Functional Motor Disorder Workbook
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.
SF-36 Health Survey (SF-36)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Psychogenic Movement Disorders Rating Scale (PMDRS)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Generalized Anxiety Disorder (GAD-7)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Health Questionnaire (PHQ-9)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Health Questionnaire (PHQ-15)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Posttraumatic Scale Checklist-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Global Assessment of Functioning (GAF)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Severity (CGI-S)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Improvement (CGI-I)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
World Health Organization: Quality of Life - BREF (WHOQOL-BREF)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Multidimensional Health Locus of Control (MHLC-C)
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Traumatic Life Events Questionnaire (TLEQ)
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.
Time frame: Baseline
Montreal Cognitive Assessment (MoCA)
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.
Time frame: Baseline, Week 12, and 12 Months
Abnormal Movement Log
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.
Time frame: Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months
Status Survey
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.
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will be available after termination of the embargo period until IRB closure.
Access criteria: Data will be made available to authors with regulatory approval upon reasonable request to the study Principal Investigator.
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