A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
研究概览
简要总结
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.
详细描述
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 100 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
- •Individuals aged 18-100 years
- •At least 1 mFND symptom during the year prior to enrollment
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Neuro-behavioral Therapy (Behavioral)
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.
干预措施: Standard Medical Care (SMC) (Other)
结局指标
主要结局
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
时间窗: 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.
SF-36 Health Survey (SF-36)
时间窗: 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)
时间窗: 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.
次要结局
- Multidimensional Health Locus of Control (MHLC-C)(Baseline, Week 6, Week 12, 8 Months and 12 Months)
- Traumatic Life Events Questionnaire (TLEQ)(Baseline)
- Montreal Cognitive Assessment (MoCA)(Baseline, Week 12, and 12 Months)
- 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)
- Clinical Global Impressions - Severity (CGI-S)(Baseline, Week 6, Week 12, 8 Months and 12 Months)
- Clinical Global Impressions - Improvement (CGI-I)(Baseline, Week 6, Week 12, 8 Months and 12 Months)
- World Health Organization: Quality of Life - BREF (WHOQOL-BREF)(Baseline, Week 6, Week 12, 8 Months and 12 Months)
- Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1(Baseline, Week 6, Week 12, 8 Months and 12 Months)
研究者
W. Curt LaFrance Jr., MD, MPH
Professor / Principal Investigator
Rhode Island Hospital