Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731078
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
David Lewis Perez, Massachusetts General Hospital

Tracking Information
First Submitted Date November 2, 2018
First Posted Date November 6, 2018
Last Update Posted Date March 11, 2019
Estimated Study Start Date March 8, 2019
Estimated Primary Completion Date January 2, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2018)
Short Form Health Survery 36 (SF-36) [ Time Frame: 1-5 years ]
questionnaire to identify change in health-related quality of life post vs. pre-treatment
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03731078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 2, 2018)
  • Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD) [ Time Frame: 1-5 years ]
    composite score post vs. pre-treatment
  • Patient Health Questionnaire-15 (PHQ-15) [ Time Frame: 1-5 years ]
    composite score post vs. pre-treatment
  • Clinical Global Impressions (CGI) - clinician rated scale [ Time Frame: 1-5 years ]
    clinical global impression of improvement as rated by clinician
  • Clinical Global Impressions (CGI) - patient rated [ Time Frame: 1-5 years ]
    clinical global impression of improvement as rated by patient
  • 10meter walk test [ Time Frame: 1-5 years ]
    change in post vs. pre-treatment speed of walking at preferred pace
  • Five Times Sit to Stand test [ Time Frame: 1-5 years ]
    change in post vs. pre-treatment time to move from sitting to standing five times
  • Simplified Functional Movement Disorders Rating Scale (S-FMDRS) [ Time Frame: 1-5 years ]
    clinician rated functional neurological symptom severity scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
Official Title Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
Brief Summary

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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population motor functional neurological disorder
Condition Functional Neurological Disorder
Intervention Other: CBT Informed physical therapy Intervention
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.
Study Groups/Cohorts 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.
Intervention: Other: CBT Informed physical therapy Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 2, 2018)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2, 2024
Estimated Primary Completion Date January 2, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David L Perez, MD, MMSc 617-724-7243 dlperez@partners.org
Contact: Julie B Maggio, PT, DPT, NCS 617-724-7243 jmaggio4@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03731078
Other Study ID Numbers 2018P001674
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Lewis Perez, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: David L Perez, MD, MMSc Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019