CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Standard of Careother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03398070
NCT03398070N/ACompleted

Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders

Massachusetts General Hospital·observational·Posted Jan 12, 2018·Updated Aug 29, 2023

In Brief

An observational study evaluating Standard of Care for Conversion Disorder. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Nonepileptic Seizures, Functional Movement Disorders and Functional Weakness. Clinical research across these motor FND subtypes, including research studies from the candidate's laboratory, suggest that these populations share many clinical and phenotypic similarities that warrant increased research integration. Furthermore, despite the prevalence of motor FND, little is known about the underlying pathophysiology of this condition, which is a prerequisite for the development of biologically informed prognostic and treatment response biomarkers. Across 3 published neurobiologically focused articles, the candidate proposed a framework through which to conceptualize motor FND. It is suggested that motor FND develops in the context of structural and functional alterations in neurocircuits mediating emotion awareness/expression, bodily awareness, viscerosomatic processing and behavioral regulation. The overall goal of this project is to comprehensively investigate structural and functional magnetic resonance imaging (MRI) biomarkers of prognosis across motor FND. Multimodal structural and functional MRI techniques (including voxel-based morphometry, cortical thickness, resting-state functional connectivity and diffusion tensor imaging tractography) will be used to systemically probe brain-prognosis relationships. Novel aspects of this proposal include the study of the full spectrum of motor FND, consistent with a trans-diagnostic approach.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 12, 2018
Enrollment StartSep 1, 2017
Primary CompletionJan 20, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.5 years ago

Interventions

Standard of Careother

The standard of care interventions for Functional Neurological Disorders (FND) include: 1. delivery of a rule-in diagnosis 2. providing educational materials 3. referring to physical therapy (PT) and/or occupational therapy (OT) as clinically indicated 4. referring to FND-related cognitive behavioral therapy (CBT) 5. psychotropic medication management based on standard psychiatric care