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

NCT03731078 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2021-09-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • David L Perez, MD, MMSc · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731078 on ClinicalTrials.gov