NCT03398070

Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders

Completed Results posted Last updated 29 August 2023

What this trial tests

trial testing Standard of Care in Conversion Disorder in 30 participants. Completed in 20 January 2023.

Timeline

1 September 2017

Primary endpoint
20 January 2023

20 January 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 September 2017
Primary completion	20 January 2023
Estimated completion	20 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Standard of Care

Conditions studied

• Conversion Disorder — all drugs for Conversion Disorder →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Conversion Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gray Matter Volume Biomarkers of 6 Month Prognosis as Measured by Voxel Based Morphometry - Within Group Comparison Primary · baseline and 6 months

Correcting for multiple comparisons in structural analyses, baseline structural grey matter volumes in limbic/paralimbic regions (particularly those affiliated with the salience network), would relate to clinical outcome in individuals receiving the standard of care at 6 months. Analyses reported refer to change in either mental health or physical health scores and baseline gray matter volume. The number presented is the peak voxel z-score as also reported in Supplementary Table 4 of the published manuscript. Z-scores are presented in absolute values (with the lowest value being 0). A higher

∆SF-36 Mental Health Positive Associations: R supplementary motor area (6): 10mm, -16mm, 75mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	4.18

∆SF-36 Mental Health Positive Associations: R superior frontal gyrus (6): 18mm, -7mm, 72mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.27

∆SF-36 Mental Health Positive Associations: R middle cingulate gyrus (24): 3mm, 12mm, 43mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.85

∆SF-36 Mental Health Positive Associations: L anterior hippocampus: -34mm, -16mm, -15mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.76

∆SF-36 Mental Health Positive Associations: L middle frontal gyrus (46): -33mm, 26mm, 40mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.61

∆SF-36 Physical Health Positive Associations: R frontopolar cortex (10): 10mm, 62mm, 4mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.90

∆SF-36 Physical Health Negative Associations: R superior/middle frontal gyrus (9): 22mm, 24mm, 37mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	4.40

∆SF-36 Physical Health Negative Associations: L superior occipital gyrus (19): -10mm, -82mm, 45mm

Group	Value	95% CI
Motor Functional Neurological Disorder.	3.80

Resting State Functional Connectivity Strength Biomarkers of 6 Month Prognosis - Within Group Comparison Primary · baseline and 6 months

Correcting for multiple comparisons in resting state connectivity analyses, baseline functional connectivity strength (t-statistic scores) across limbic/paralimbic regions (particularly those affiliated with the salience network), would relate to clinical outcome in individuals receiving the standard of care at 6 months. Here, we tested if link-step connectivity from primary motor areas or amygdala nuclei related to change in clinical outcome. Specifically, we are providing the t-statistic for the connectivity strength between left centromedial amygdala to right anterior insula. Functional co

Group	Value	95% CI
Motor Functional Neurological Disorder.	4.58

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.