An observational study in Functional Neurological Symptom Disorder, Paralysis and Conversion Disorder with Weakness/Paralysis, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Swiss Paraplegic Research, Nottwil · Observational
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.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's enrollment of 69 is above the median of 60 across 37 observational studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →Swiss Paraplegic Research, Nottwil is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
FND patients are recruited at the Swiss Paraplegic Centre and the Inselspital Bern. Inpatient and outpatient SCI subjects are recruited in the Swiss Paraplegic Centre .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy participants
Diagnostic Test: Magnetic Resonance Imaging (MRI)
People with the subtype functional paralysis
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Incomplete and complete paralysis with the ability to hold a pen
Diagnostic Test: Magnetic Resonance Imaging (MRI)
In order to investigate the metabolic profile, magnetic resonance spectroscopy (MRS) will be applied. Functional MRI (fMRI) allows to indirectly track cell activation measuring the blood-level dependent signal changes followed spontaneously (in resting state) or evoked by a task. Diffusion weighted imaging (DWI) is based on the differences in motion of the water molecules given by the underlying microarchitecture of the nervous tissue. Diffusion tensor imaging (DTI) allows visualisation of the nerve bundles and alterations thereof. Thus, microstructural alterations can be measured.
Also known as: Functional Magnetic Resonance Imaging (fMRI), In-vivo Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI)
Nerve Cell Metabolism
With MRS metabolites are examined specific for cell integrity (N-acetyl-aspartate), cell energy (creatine, lactate), and neurotransmitter (choline, glutamate and glutamine).
Time frame: day 1
Brain Functional Connectivity
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.
Time frame: day 1
Fiber tracts in three dimensional mapping
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.
Time frame: day 1
Satisfaction with Life Scale questionnaire
Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total
Time frame: day 1
Hospital Anxiety and Depression Scale questionnaire
Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total
Time frame: day 1
Numerical Rating Scale (NRS) questionnaire
Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)
Time frame: day 1
Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)
A key point in each of the 28 dermatomes is tested bilaterally using light touch and pin-prick (sharp-dull discrimination). A three-point scale is used for scoring: 0 = absent 1. = altered (impaired or partial appreciation, including hyperesthesia) 2. = normal or intact (similar as on the cheek) not testable
Time frame: day 1
Plan to share: No
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Ran from Nov 2022 to primary completion in Feb 2024, 15 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Swiss Paraplegic Research, Nottwil