Exploring Functional Paralysis With Advanced Magnetic Resonance Modalities

Paralysis Clinical Trial

Official title:

Exploring Functional Paralysis With Advanced Magnetic Resonance Modalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139732
• Other study ID #: 2021-10
• Status: Completed
• Start date: November 4, 2022
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Functional Neurological Symptom Disorder
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Research	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Satisfaction with Life Scale questionnaire	Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total	day 1
Secondary	Hospital Anxiety and Depression Scale questionnaire	Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total	day 1
Secondary	Numerical Rating Scale (NRS) questionnaire	Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)	day 1
Secondary	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; = altered (impaired or partial appreciation, including hyperesthesia); = normal or intact (similar as on the cheek) not testable	day 1