Clinical trial NCT06873698: Pilot Neurobehavioral Therapy for Functional Neurological Disorder
Official title: A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Neurological Disorder
Keywords: mFND
Conversion Disorder
Functional Neurologic Disorder
Neurobehavioral Therapy
FND
Psychogenic Movement Disorder
Psychotherapy
motor functional neurological disorder
functional motor disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SF-36 Health Survey (SF-36)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Psychogenic Movement Disorders Rating Scale (PMDRS)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Patient Health Questionnaire (PHQ-15)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Posttraumatic Scale Checklist-5 (PCL-5)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Clinical Global Impressions - Severity (CGI-S)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: World Health Organization: Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Multidimensional Health Locus of Control (MHLC-C)
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
measure: Traumatic Life Events Questionnaire (TLEQ)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, Week 12, and 12 Months
Other outcomes:
measure: Abnormal Movement Log
timeFrame: Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months
measure: Status Survey
timeFrame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Brown University Health
name: W. Curt LaFrance Jr, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University Health
name: Emily Weisbach, MD
role: STUDY_CHAIR
References:
citation: LaFrance WC Jr, Tedesco R, Baird GL, Wincze J, Tocco K, Anderson J. Clinician-rated outcomes of patients with functional neurological disorders treated in an outpatient clinic. Seizure. 2023 Apr;107:21-27. doi: 10.1016/j.seizure.2023.03.005. Epub 2023 Mar 12.