Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities

NCT05139732 | Completed

• 1 other identifier: 2021-10
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Symptom Disorder; Paralysis; Conversion Disorder with Weakness/Paralysis

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  day 1

Secondary Outcomes (4)

• 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

Study Arms (3)

control

Healthy participants

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Functional Neurological Disorder (FND)

People with the subtype functional paralysis

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Spinal Cord Injury (SCI)

Incomplete and complete paralysis with the ability to hold a pen

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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)

Functional Neurological Disorder (FND); Spinal Cord Injury (SCI); control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 .

You may qualify if:

• Age between 18-65

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Conversion Disorder; Paralysis

Interventions

Magnetic Resonance Imaging; Diffusion Tensor Imaging; Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Neuroimaging; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: November 4, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)