N/A
N=30
Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders
Conversion Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03398070 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Gray Matter Volume Biomarkers of 6 Month Prognosis as Measured by Voxel Based Morphometry - Within Group Comparison — 4.18; 3.27; 3.85; 3.76 peak voxel z-score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gray Matter Volume Biomarkers of 6 Month Prognosis as Measured by Voxel Based Morphometry - Within Group Comparison |
4.18; 3.27; 3.85; 3.76; 3.61; 3.90 | — |
| PRIMARY Resting State Functional Connectivity Strength Biomarkers of 6 Month Prognosis - Within Group Comparison |
4.58 | — |
| PRIMARY The Integrity of Specific White Matter Tracts (Fractional Anisotropy) as Measured by Diffusion Tensor Imaging (DTI) Tractography Will Relate to 6-month Prognosis |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- clinically established motor functional neurological disorder, including individuals with functional movement disorders, functional limb weakness and psychogenic nonepileptic seizures
Exclusion Criteria
- active suicidality
- major medical/neurological comorbidities with known central nervous system (CNS) consequences
- active drug use or alcohol dependence
- known history of a primary psychotic disorder
Data sourced from ClinicalTrials.gov (NCT03398070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.