Pilot Neurobehavioral Therapy for Functional Neurological Disorder
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Neuro-behavioral Therapy, Standard Medical Care (SMC).
- Кому может быть актуально
- Состояния в реестре: Functional Neurological Disorder. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
Обзор
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.
Подробное описание
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).
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.
Вмешательства
- Поведенческое 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). - Другое 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.
Первичные конечные точки
- SF-36 Health Survey (SF-36) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Psychogenic Movement Disorders Rating Scale (PMDRS) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Simplified Functional Movement Disorders Rating Scale (S-FMDRS) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
Вторичные конечные точки (12)
- Generalized Anxiety Disorder (GAD-7) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Patient Health Questionnaire (PHQ-15) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Posttraumatic Scale Checklist-5 (PCL-5) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Global Assessment of Functioning (GAF) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Clinical Global Impressions - Severity (CGI-S) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Clinical Global Impressions - Improvement (CGI-I) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- World Health Organization: Quality of Life - BREF (WHOQOL-BREF) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1 [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Multidimensional Health Locus of Control (MHLC-C) [Срок оценки: Baseline, Week 6, Week 12, 8 Months and 12 Months]
- Traumatic Life Events Questionnaire (TLEQ) [Срок оценки: Baseline]
- Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, Week 12, and 12 Months]
Критерии участия
Критерии включения
- Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
- Individuals aged 18-100 years
- At least 1 mFND symptom during the year prior to enrollment
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Rhode Island Hospital — Providence
Публикации
- 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
Идентификаторы
NCT: NCT06873698 · 2136841