Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities

November 27, 2024 updated by: Swiss Paraplegic Research, Nottwil

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Lucerne
      • Nottwil, Lucerne, Switzerland, 6207
        • Swiss Paraplegic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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 .

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control
Healthy participants
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.
Other Names:
  • Functional Magnetic Resonance Imaging (fMRI)
  • In-vivo Magnetic Resonance Spectroscopy (MRS)
  • Diffusion Tensor Imaging (DTI)
  • Diffusion Weighted Imaging (DWI)
Functional Neurological Disorder (FND)
People with the subtype functional paralysis
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.
Other Names:
  • Functional Magnetic Resonance Imaging (fMRI)
  • In-vivo Magnetic Resonance Spectroscopy (MRS)
  • Diffusion Tensor Imaging (DTI)
  • Diffusion Weighted Imaging (DWI)
Spinal Cord Injury (SCI)
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.
Other Names:
  • Functional Magnetic Resonance Imaging (fMRI)
  • In-vivo Magnetic Resonance Spectroscopy (MRS)
  • Diffusion Tensor Imaging (DTI)
  • Diffusion Weighted Imaging (DWI)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nerve Cell Metabolism
Time Frame: day 1
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
Time Frame: 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.
day 1
Fiber tracts in three dimensional mapping
Time Frame: 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.
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with Life Scale questionnaire
Time Frame: day 1
Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total
day 1
Hospital Anxiety and Depression Scale questionnaire
Time Frame: day 1
Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total
day 1
Numerical Rating Scale (NRS) questionnaire
Time Frame: day 1
Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)
day 1
Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)
Time Frame: 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
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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