Pilot Neurobehavioral Therapy for Functional Neurological Disorder

NCT ID: NCT06873698

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2028-06-30

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.

Conditions

Functional Neurological Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuro-behavioral Therapy

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Standard Medical Care (SMC)

Intervention Type: 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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Taking Control of Your Functional Motor Disorder Workbook

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

W. Curt LaFrance Jr., MD, MPH

Professor / Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

W. Curt LaFrance Jr, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brown University Health

Emily Weisbach, MD

Role: STUDY_CHAIR

Brown University Health

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexis Sr. Clinical Research Assistant

Role: CONTACT

ademarco@brownhealth.org

401-606-4651

Deepica Clinical Research Program Coordinator

Role: CONTACT

dchaudhary@brownhealth.org

401-606-4655

References

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.

Reference Type: BACKGROUND

PMID: 36933399 (View on PubMed)

Other Identifiers

2136841

Identifier Type: -

Identifier Source: org_study_id