Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders
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|ClinicalTrials.gov Identifier: NCT03398070|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment|
|Conversion Disorder||Other: Standard of Care|
Functional Neurological Disorder (FND) (Conversion Disorder) is a poorly understood and prevalent somatoform disorder, making up 16% of outpatient neurology referrals. Patients with motor FND (mFND) are difficult to treat, result in major morbidity, and are costly to the US. An estimated $256 billion is spent annually treating this population. mFND includes Nonepileptic Seizures (NES), Functional Movement Disorders (FMD) and Functional Weakness (FW). An impediment to managing mFND is the lack of a neurobiological understanding for this disorder. The diagnosis of mFND is currently based on qualitative aspects of behaviors, which may be difficult to interpret, and the absence of findings characteristic of other neuropsychiatric disorders on laboratory studies such as electroencephalography (EEG) and magnetic resonance imaging (MRI).
A major step forward would be the identification of neuroimaging biomarkers for mFND. mFND is understudied compared to other disorders, but recent studies point to distributed neurocircuit alterations associated with mFND. This project aims to advance our biological understanding of mFND by investigating neuroimaging biomarkers linked to prognosis. An improved understanding of the neuropathophysiology of mFND will provide a critical step in elucidating diagnostic, prognostic and treatment response biomarkers.
Identify structural and functional biomarkers of prognosis at 6-months in patients with motor functional neurological disorders receiving an updated standard of care.
H1: Favorable mFND prognosis at 6 months post initial evaluation will be predicted by the degree of preserved baseline gray matter in limbic-paralimbic regions, particularly those part of the salience network.
H2: Favorable mFND prognosis at 6 months post initial evaluation will be predicted by the degree of preserved baseline resting-state functional connectivity in limbic/paralimbic areas, particularly those part of the salience network.
H3: Favorable mFND prognosis at 6 months will correlate with the degree of preserved baseline cingulum bundle and cingulo-insular tract integrity.
|Study Type :||Observational|
|Estimated Enrollment :||49 participants|
|Official Title:||Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Motor Functional Neurological Disorder.
The cohort will consist of patients with clinically established motor functional neurological disorder, which includes individuals with functional movement disorders, psychogenic nonepileptic seizures and functional limb weakness.
Patients will be receiving the standard of care within the Massachusetts General Hospital (MGH) Functional Neurological Disorders Clinic.
The updated standard of care that patient's receive in the MGH Functional Neurological Disorders Clinic includes the following:
Other: Standard of Care
The standard of care interventions for Functional Neurological Disorders (FND) include:
- Gray Matter Volume Biomarkers of 6 Month Prognosis as measured by Voxel Based Morphometry [ Time Frame: 2-4 years ]Correcting for multiple comparisons in structural analyses, baseline structural grey matter volumes in limbic/paralimbic regions (particularly those affiliated with the salience network), would be predictive of clinical outcome in individuals receiving the standard of care at 6 months.
- Resting State Functional Connectivity Strength Biomarkers of 6 Month Prognosis [ Time Frame: 3-5 years ]Correcting for multiple comparisons in resting state connectivity analyses, baseline functional connectivity strength (Pearson correlation coefficients) across limbic/paralimbic regions (particularly those affiliated with the salience network), would be predictive of clinical outcome in individuals receiving the standard of care at 6 months.
- The integrity of specific white matter tracts (fractional anisotropy) as measured by diffusion tensor imaging (DTI) tractography will relate to 6-month prognosis [ Time Frame: 3-5 years ]Baseline integrity of the cingulum bundle and cingulate-insular tracts, as measured by fractional anisotropy, would be predictive of 6 month prognosis in patients with Functional Neurological Disorders (FND) receiving the standard of care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398070
|Contact: David L Perez, MD, MMScemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: David L Perez, MD, MMSc 617-724-7243 firstname.lastname@example.org|