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NCT03398070 · ClinicalTrials.gov registry record
Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 30
- Enrollment target
NCT03398070: Completed study, sponsored by Massachusetts General Hospital.
NCT03398070 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03398070 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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 publish
Interventions
- OTHER Standard of Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2023-01-20 |
What the finished NCT03398070 record still lists
NCT03398070 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Standard of Care is the first listed.
NCT03398070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03398070 about?
NCT03398070 is a clinical study titled "Neuroimaging Biomarkers of Prognosis in Motor Functional Neurological Disorders". 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 s...
What is the current status of trial NCT03398070?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2017-09-01. Estimated completion is 2023-01-20.
What interventions are being tested in trial NCT03398070?
The interventions under investigation include: Standard of Care (OTHER).
Who is sponsoring clinical trial NCT03398070?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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