Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Not Applicable

Recruiting

• Conditions: Functional Neurological Disorder

• Registration Number: NCT06873698
• Lead Sponsor: Rhode Island Hospital

Brief 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.

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 70 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 Timeline

• Study Start: 2024-09-25
• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2028-01
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
• Individuals aged 18-70 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SF-36 Health Survey (SF-36)	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.
Psychogenic Movement Disorders Rating Scale (PMDRS)	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.
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)	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.

Secondary Outcome Measures

Name	Time	Method
Multidimensional Health Locus of Control (MHLC-C)	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.
Traumatic Life Events Questionnaire (TLEQ)	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.
Montreal Cognitive Assessment (MoCA)	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.
Generalized Anxiety Disorder (GAD-7)	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.
Patient Health Questionnaire (PHQ-9)	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.
Patient Health Questionnaire (PHQ-15)	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.
Posttraumatic Scale Checklist-5 (PCL-5)	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.
Global Assessment of Functioning (GAF)	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.
Clinical Global Impressions - Severity (CGI-S)	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.
Clinical Global Impressions - Improvement (CGI-I)	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.
World Health Organization: Quality of Life - BREF (WHOQOL-BREF)	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.
Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1	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.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States