Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Neurological Symptom Disorder
- Sponsor
- Swiss Paraplegic Research, Nottwil
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Nerve Cell Metabolism
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI).
The aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects.
The overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18-65
Exclusion Criteria
- •Contraindication for magnetic resonance examinations (e.g. cardiac pacemaker, pregnancy, etc.)
- •history of mental or neurological illness (addiction, central nervous system tumour and severe craniocerebral trauma)
- •unable to hold a pen due to paralysis
Outcomes
Primary Outcomes
Nerve Cell Metabolism
Time Frame: day 1
With MRS metabolites are examined specific for cell integrity (N-acetyl-aspartate), cell energy (creatine, lactate), and neurotransmitter (choline, glutamate and glutamine).
Fiber tracts in three dimensional mapping
Time Frame: day 1
DWI provides quantitative evaluations by measuring the apparent diffusion coefficient (ADC) and fractional anisotropy (FA), which are scalars of isotropic and anisotropic diffusion. Diffusion tensor imaging (DTI) analyses the three-dimensional shape of the diffusion, also known as diffusion tensor. So, it is used to characterize the magnitude, the degree of anisotropy, and the orientation of directional diffusion of white matter.
Brain Functional Connectivity
Time Frame: day 1
With fMRI in rest and task condition, the functional connectivity (FC) is examined. With that the functionally integrated relationship between spatially separated brain regions are investigated.
Secondary Outcomes
- Satisfaction with Life Scale questionnaire(day 1)
- Hospital Anxiety and Depression Scale questionnaire(day 1)
- Numerical Rating Scale (NRS) questionnaire(day 1)
- Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)(day 1)