Functional Neurological Symptom DisorderNCT05139732
Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
An observational study of Functional Neurological Symptom Disorder and Paralysis, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Neurological Symptom Disorder, Paralysis, Conversion Disorder with Weakness/Paralysis
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Nov 2022to 8 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- Age between 18-65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
About this study
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
- Being tested
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Conversion Disorder, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Also called Functional Magnetic Resonance Imaging (fMRI), In-vivo Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI)
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.
| Study group | Role | What they receive |
|---|---|---|
| control | Healthy participants Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| Functional Neurological Disorder (FND) | People with the subtype functional paralysis Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| Spinal Cord Injury (SCI) | Incomplete and complete paralysis with the ability to hold a pen Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: day 1
Secondary outcomes (4)
Satisfaction with Life Scale questionnaire
Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total
Measured: day 1
Hospital Anxiety and Depression Scale questionnaire
Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total
Measured: day 1
Numerical Rating Scale (NRS) questionnaire
Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)
Measured: day 1
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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start4 Nov 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological Symptom DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139732
- Sponsor's protocol ID
- 2021-10
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
- ClinicalTrials.gov ID
- NCT05139732
- Acronym / sponsor ID
- 2021-10
- Conditions
- Functional Neurological Symptom Disorder, Paralysis, Conversion Disorder with Weakness/Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)Healthy participants |
| Functional Neurological Disorder (FND) | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)People with the subtype functional paralysis |
| Spinal Cord Injury (SCI) | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)Incomplete and complete paralysis with the ability to hold a pen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (1 listed)
- Age between 18-65
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Also: Functional Magnetic Resonance Imaging (fMRI), In-vivo Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI)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. | Diagnostic test | Functional Neurological Disorder (FND), Spinal Cord Injury (SCI), control |
Primary outcome
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).
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.
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.
4 secondary outcomes
Satisfaction with Life Scale questionnaire
Time frame: day 1
Hospital Anxiety and Depression Scale questionnaire
Time frame: day 1
Numerical Rating Scale (NRS) questionnaire
Time frame: day 1
Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Symptom Disorder and Paralysis, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Cell Metabolism (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.