Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders
NCT ID: NCT03398070
Last Updated: 2023-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2017-09-01
2023-01-20
Brief Summary
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Detailed Description
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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 pathophysiology of mFND will provide a critical step in elucidating diagnostic, prognostic and treatment response biomarkers.
Aim:
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 cingulum-insular tract integrity.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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:
1. Delivery of a positive "rule-in" diagnosis of functional neurological disorder
2. Individuals are provided with educational materials on functional neurological disorders
3. Referred to physical therapy and/or occupational therapy as clinically indicated
4. FND related cognitive behavioral therapy (CBT) referral when appropriate
5. Psychotropic medication management based on standard psychiatric care
Standard of Care
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
Interventions
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Standard of Care
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* major medical/neurological comorbidities with known central nervous system (CNS) consequences
* active drug use or alcohol dependence
* known history of a primary psychotic disorder
18 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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David Lewis Perez
Principal Investigator
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Diez I, Ortiz-Teran L, Williams B, Jalilianhasanpour R, Ospina JP, Dickerson BC, Keshavan MS, LaFrance WC Jr, Sepulcre J, Perez DL. Corticolimbic fast-tracking: enhanced multimodal integration in functional neurological disorder. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):929-938. doi: 10.1136/jnnp-2018-319657. Epub 2019 Mar 8.
Perez DL, Williams B, Matin N, Mello J, Dickerson BC, LaFrance WC Jr, Keshavan MS. Anterior hippocampal grey matter predicts mental health outcome in functional neurological disorders: an exploratory pilot study. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1221-1224. doi: 10.1136/jnnp-2017-317305. Epub 2018 Jan 11. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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See Figure 5 for relevant results
See Figure 1 for relevant results
Other Identifiers
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