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NCT03731078 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Massachusetts General Hospital.

Terminated
Registry status
4
Enrollment target

NCT03731078: Clinical Trial study, sponsored by Massachusetts General Hospital.

NCT03731078 is a clinical trial that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03731078 was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
4 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • OTHER CBT Informed physical therapy Intervention

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2019-03-08
Est. Completion 2021-09-01
Massachusetts General Hospital

2,032 total trials

Why NCT03731078 stopped before completion

NCT03731078 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which CBT Informed physical therapy Intervention is the first listed.

NCT03731078 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03731078 about?

NCT03731078 is a clinical study titled "Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders". 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...

What is the current status of trial NCT03731078?

This trial is currently terminated. The enrollment target is 4 participants. The study started on 2019-03-08. Estimated completion is 2021-09-01.

What interventions are being tested in trial NCT03731078?

The interventions under investigation include: CBT Informed physical therapy Intervention (OTHER).

Who is sponsoring clinical trial NCT03731078?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03731078, the US trial registry maintained by the National Library of Medicine. NCT03731078 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.