Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Short Form Health Survery 36 (SF-36)
研究概览
简要总结
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Functional Movement Disorders (FMD) and Functional Weakness and Psychogenic Nonepileptic Seizures (PNES).Though patients with FND present with a wide variety of symptoms, FMD, PNES, and functional weakness may be viewed as overlapping conditions lying along a phenotypic spectrum for a single disorder. Patients with FND frequently present with psychiatric symptoms, including depression, anxiety, Borderline Personality Disorder, and Post-Traumatic Stress Disorder, alongside their physical symptoms. To treat these symptoms, patients with FND are frequently enrolled in physical therapy and cognitive behavioral therapy, which are considered usual care for FND at our center. Developing a further understanding of treatment outcome, including biomarkers of clinical improvement and psychometric factors associated with treatment response, could inform future interventions and better tailor treatments to patients with specific FND symptom profiles.
We hypothesize that treatment response will be associated with structural and functional alterations in salience network regions and that more adaptive neuropsychiatric profiles at baseline will predict a positive treatment outcome.
详细描述
Functional Neurological Disorder (FND) (Conversion Disorder) is a poorly understood and prevalent somatoform disorder, making up 16% of outpatient neurology referrals. Patients with motor FND (mFND) are difficult to treat, result in major morbidity, and are costly to the US. An estimated $256 billion is spent annually treating this population. mFND includes Functional Movement Disorders (FMD), Functional Weakness (FW) and Psychogenic Nonepileptic Seizures (PNES).
This project will investigate brain network profiles associated with and predictive of clinical improvement in patients with Functional Neurological Disorder (FND) following a 12-week cognitive behavioral therapy-informed physical therapy treatment program. Integrated physical therapy along with self-guided cognitive behavioral therapy is usual care for patients with FND experiencing motor symptoms at the Massachusetts General Hospital. Patients with motor FND experience significant impairment and often face issues with treatment management. Recent advancements in clinical research, catalyzed by new diagnostic criteria and an updated care model, have emphasized physical therapy and cognitive behavioral therapy as important evidence-based treatments for this population. Additionally, developments in neuroscience have allowed for a more comprehensive understanding of the neurobiology of FND. However, there has been limited investigation of longitudinal biomarkers associated with and predictive of treatment response, highlighting the need for an improved understanding of neurobiological changes underlying prognosis in FND.
We propose acquiring structural and functional brain imaging data in combination with psychometric assessments and patient chart review to examine neurobiological mechanisms of associated with participation in a cognitive behavioral therapy-informed physical therapy treatment program for patients with FND.
Primary Aim and Hypotheses The primary goal of this study is to provide structural and functional biomarkers related to and predictive of treatment response and clinical outcome in patients with motor FND following a 12-week cognitive behavioral therapy-informed physical therapy treatment program (usual care).
Specific Aim 1:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FND patients will be recruited from the FND clinic and allied neurology and psychiatry clinics at Massachusetts General Hospital, with additional recruitment occurring through the physical therapy department. This study aims to recruit a total of 70 patients with motor FND. FND subjects will meet established clinical diagnostic criteria and patients with functional weakness will be diagnosed by "positive" signs suggestive of functional weakness including but not limited to a positive Hoover's sign. Individuals with PNES who have a concurrent functional limb weakness and/or a functional movement disorder will also be recruited. In addition, all individuals will have a clinical indication for PT (i.e. limb weakness, gait difficulties, abnormal movements).
排除标准
- •Any significant major neurological disorder resulting in specific MRI abnormalities (i.e. encephalomalacia, severe traumatic brain injury (TBI)), poorly controlled major medical illness with known central nervous system consequences, inability to read English, pregnancy, claustrophobia, or inability to satisfy MRI safety measures. Additionally, patients with isolated PNES will not be considered for this study.
- •Note: individuals who are eligible for the study but have an MRI contraindication may be offered study enrollment with MRI data collection for participation in aim 3 of this study.
结局指标
主要结局
Short Form Health Survery 36 (SF-36)
时间窗: 1-5 years
questionnaire to identify change in health-related quality of life post vs. pre-treatment
次要结局
- Clinical Global Impressions (CGI) - patient rated(1-5 years)
- 10meter walk test(1-5 years)
- Patient Health Questionnaire-15 (PHQ-15)(1-5 years)
- Simplified Functional Movement Disorders Rating Scale (S-FMDRS)(1-5 years)
- Clinical Global Impressions (CGI) - clinician rated scale(1-5 years)
- Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD)(1-5 years)
- Five Times Sit to Stand test(1-5 years)
研究者
David Lewis Perez
Principal Investigator
Massachusetts General Hospital