Pilot Neurobehavioral Therapy for Functional Neurological Disorder

NCT06873698 | Recruiting

• 1 other identifier: 2136841
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Week 6, Week 12, 8 Months and 12 Months

Secondary Outcomes (12)

• Generalized Anxiety Disorder (GAD-7)

  Baseline, Week 6, Week 12, 8 Months and 12 Months

• Patient Health Questionnaire (PHQ-9)

  Baseline, Week 6, Week 12, 8 Months and 12 Months

• Patient Health Questionnaire (PHQ-15)

  Baseline, Week 6, Week 12, 8 Months and 12 Months

• Posttraumatic Scale Checklist-5 (PCL-5)

  Baseline, Week 6, Week 12, 8 Months and 12 Months

• Global Assessment of Functioning (GAF)

  Baseline, Week 6, Week 12, 8 Months and 12 Months

Other Outcomes (2)

• Abnormal Movement Log

  Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months

• Status Survey

  Baseline, Week 6, Week 12, 8 Months and 12 Months

Study Arms (2)

Neuro-Behavioral Therapy

EXPERIMENTAL

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

Standard Medical Care

ACTIVE COMPARATOR

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)

Interventions

Neuro-behavioral Therapy BEHAVIORAL

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

Neuro-Behavioral Therapy

Standard Medical Care (SMC) OTHER

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.

Standard Medical Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
• Individuals aged 18-70 years
• At least 1 mFND symptom during the year prior to enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36933399 BACKGROUND

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• W. Curt LaFrance Jr, MD, MPH

  Brown University Health

  PRINCIPAL INVESTIGATOR

• Emily Weisbach, MD

  Brown University Health

  STUDY CHAIR

Central Study Contacts

Alexis Sr. Clinical Research Assistant

CONTACT

401-606-4651; ademarco@brownhealth.org

Deepica Clinical Research Program Coordinator

CONTACT

401-606-4655; dchaudhary@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: September 25, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)