Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Description

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

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Study Overview

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Study Details

Study overview

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.

A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)

Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Condition
Functional Neurological Disorder
Intervention / Treatment

-

Contacts and Locations

Providence

Rhode Island Hospital, Providence, Rhode Island, United States, 02903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rhode Island Hospital,

W. Curt LaFrance Jr, MD, MPH, PRINCIPAL_INVESTIGATOR, Brown University Health

Emily Weisbach, MD, STUDY_CHAIR, Brown University Health

Study Record Dates

2028-06