Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities

NCT ID: NCT05139732

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2024-02-08

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

control

Healthy participants

Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Functional Neurological Disorder (FND)

People with the subtype functional paralysis

Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Spinal Cord Injury (SCI)

Incomplete and complete paralysis with the ability to hold a pen

Magnetic Resonance Imaging (MRI)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Functional Magnetic Resonance Imaging (fMRI); In-vivo Magnetic Resonance Spectroscopy (MRS); Diffusion Tensor Imaging (DTI); Diffusion Weighted Imaging (DWI)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

2021-10

Identifier Type: -

Identifier Source: org_study_id