Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
- Conditions
- Functional Neurological Symptom DisorderParalysisConversion Disorder with Weakness/Paralysis
- Interventions
- Diagnostic Test: Magnetic Resonance Imaging (MRI)
- Registration Number
- NCT05139732
- Lead Sponsor
- Swiss Paraplegic Research, Nottwil
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- Age between 18-65
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Functional Neurological Disorder (FND) Magnetic Resonance Imaging (MRI) People with the subtype functional paralysis Spinal Cord Injury (SCI) Magnetic Resonance Imaging (MRI) Incomplete and complete paralysis with the ability to hold a pen control Magnetic Resonance Imaging (MRI) Healthy participants
- Primary Outcome Measures
Name Time Method Nerve Cell Metabolism 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 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 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 Outcome Measures
Name Time Method Satisfaction with Life Scale questionnaire day 1 Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total
Hospital Anxiety and Depression Scale questionnaire day 1 Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total
Numerical Rating Scale (NRS) questionnaire day 1 Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)
Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI) day 1 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
Trial Locations
- Locations (1)
Swiss Paraplegic Research
🇨ðŸ‡Nottwil, Lucerne, Switzerland