Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
Keywords
Abstract
Description
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:
SA1) Identify structural MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with increased volume, cortical thickness, and/or white matter integrity in salience network-related regions post- versus pre- treatment. Pre-treatment (baseline) salience network volume, cortical thickness, and/or white mater integrity will predict clinical outcome of the 12-week treatment program.
Specific Aim 2:
SA2) Identify resting-state functional MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with reduced post- versus pre- treatment salience-somatomotor network resting state functional connectivity, and pre-treatment salience-somatomotor network functional connectivity strength will predict clinical outcome.
SA3) Identify baseline psychometric factors that correlate with clinical improvement (post vs. pre-treatment), including differences among FND sub-populations and baseline predictors of clinical improvement in FND.
Hypotheses: FND patients with more adaptive psychological profiles at baseline will be more responsive to treatment.
Dates
| Last Verified: | 02/28/2019 |
| First Submitted: | 11/01/2018 |
| Estimated Enrollment Submitted: | 11/01/2018 |
| First Posted: | 11/05/2018 |
| Last Update Submitted: | 03/07/2019 |
| Last Update Posted: | 03/10/2019 |
| Actual Study Start Date: | 03/07/2019 |
| Estimated Primary Completion Date: | 01/01/2024 |
| Estimated Study Completion Date: | 01/01/2024 |
Condition or disease
Intervention/treatment
Other: Motor Functional Neurological Disorder
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Motor Functional Neurological Disorder The cohort will consist of patients with clinically-established motor functional neurological disorder, which includes individuals with functional movement disorders and functional limb weakness. Individuals with functional movement disorders and/or functional limb weakness who also have psychogenic nonepileptic seizures will be included. Patients will receive CBT informed PT intervention. The physical therapy intervention will be usual care in FND and based on consensus recommendations, clinical trials and good practices. | Other: Motor Functional Neurological Disorder The 12 physical therapy sessions delivered in Massachusetts General Hospital outpatient physical therapy sites sessions include:1) evaluation and education; 2) strategy identification and goal setting; 3) functional strengthening part one; 4) functional strengthening part two; 5) pre-gait activities with distraction; 6) gait training with distraction and use of strategies; 7) minimizing tremor with use of strategies; 8) higher level balance training; 9) functional reintegration part one; 10) functional reintegration part two; 11) identification of strategies to limit recurrence; 12) education for relapse prevention.Patients will also be given and asked to complete the self-guided CBT workbookL Overcoming Functional Neurological Symptoms: A Five Area Approach. They will be asked to complete the first two chapters over the first 4 weeks and the remaining 8 chapters over the following 8 weeks. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Outcome
Primary Outcome Measures
1. Short Form Health Survery 36 (SF-36) [1-5 years]
Secondary Outcome Measures
1. Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD) [1-5 years]
2. Patient Health Questionnaire-15 (PHQ-15) [1-5 years]
3. Clinical Global Impressions (CGI) - clinician rated scale [1-5 years]
4. Clinical Global Impressions (CGI) - patient rated [1-5 years]
5. 10meter walk test [1-5 years]
6. Five Times Sit to Stand test [1-5 years]
7. Simplified Functional Movement Disorders Rating Scale (S-FMDRS) [1-5 years]
