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

NCT03731078 | Terminated

• 1 other identifier: 2018P001674
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Disorder

Keywords

Conversion Disorder; Functional Limb Weakness; Functional Movement Disorder

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survery 36 (SF-36)

  questionnaire to identify change in health-related quality of life post vs. pre-treatment

  1-5 years

Secondary Outcomes (7)

• Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD)

  1-5 years

• Patient Health Questionnaire-15 (PHQ-15)

  1-5 years

• Clinical Global Impressions (CGI) - clinician rated scale

  1-5 years

• Clinical Global Impressions (CGI) - patient rated

  1-5 years

• 10meter walk test

  1-5 years

Study Arms (1)

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: CBT Informed physical therapy Intervention

Interventions

CBT Informed physical therapy Intervention OTHER

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.

Motor Functional Neurological Disorder

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

motor functional neurological disorder

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• David L Perez, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: March 8, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)